Scientist, Formulation Resume Sample
Carley Stanton
2931 Hilbert Trail,
Philadelphia,
PA
+1 (555) 178 5400
Work Experience
Senior Scientist, Formulation Development
02/2016
-
PRESENT
Phoenix, AZ
- Understands project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders
- Provides technical leadership to project teams within area of expertise and commits resources to execute specific project tasks
- Reviews, interprets and communicates data cross-functionally within CMC and project teams
- Plans and implements resolutions to technical problems/issues
- Independently designs and executes experiments, and reports results
- Assists with development of project strategy and communicates complex data/decisions within department and cross functionally as necessary
- Proactively analyses manufacturing issues and coordinates potential resolution with the CMC team
- Responsible for integrating scientific/technical efforts around cross-functional issues
Scientist, Formulation
12/2008
-
10/2015
Boston, MA
- Previous laboratory experience either in academia or in the Biotech industry
- Self-motivated - can function both independently as well as part of a team
- Keen to learn and progress
- Process mind-set, strong attention to detail, good work ethic, and ability to be flexible to rapid changes in priorities
- Complying with all company safety regulations and procedures and report non-compliance
- Serving as an effective safety steward by ensuring accurate reporting of near misses and attending safety trainings
- Knowledgeable of MSDS for relevant products
- Operating a safe work environment through continuous safety awareness and full compliance to all Environmental Health and Safety programs and activities
- Apply scientific know-how to design formulations and develop manufacturing processes for a wide range of dosage forms, including oral solids and liquids, topicals, otic, ophthalmic, injectables, and implants
Scientist Formulation Development
12/2004
-
08/2008
Dallas, TX
- Provide support for the development program of animal health dosage forms, both at laboratory as well as pilot scales
- Maintain high-quality documentation, independently analyze and interpret data, and prepare technical reports and external publications as appropriate
- Investigate and develop new methods and technologies for project advancement
- Demonstrated ability in making scientific presentations and writing up technical studies
- Shown examples of problem solving and critical thinking skills
- Work independently with assigned or self initiated scientific projects
- Passionate to work in a team and highly matrixed environment
- Results orientated to drive projects to completion
Education
Washington Adventist University
2000 - 2004
Bachelor's Degree in Biology
Professional Skills
- Strong technical writing skills: preparation of formulation protocols, technical reports, SOPs and batch records
- Analytical and Problem Solving Skills - Able to troubleshoot critical issues or problems, and determine causes and possible solutions
- Track record of working effectively with team-members of diverse skill sets and backgrounds
- Understanding and hands-on experience in running stability programs
- Experience writing and modifying Standard Operating Procedures
- Demonstrated excellence in independently designing and conducting experiments and analyzing data
- Hands-on experience in developing HPLC/UPLC, CE, DSC, MFI, CD, and light scattering methods for protein/mAb analysis
How to write Scientist, Formulation Resume
Scientist, Formulation role is responsible for technical, research, manufacturing, training, integration, design, insurance, travel, translation, software.
To write great resume for scientist, formulation job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Scientist, Formulation Resume
The section contact information is important in your scientist, formulation resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Scientist, Formulation Resume
The section work experience is an essential part of your scientist, formulation resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous scientist, formulation responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular scientist, formulation position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Scientist, Formulation resume experience can include:
- Good communication, project management, and interpersonal skills
- Interface with different functional groups and communicate effectively with internal and external partners
- Communicate effectively with the customer/client and internal project teams
- Experience using biophysical formulation characterization techniques such as DSC, DLS, KF, and particle sizing techniques
- Experience in a manufacturing, engineering or research environment
- Participate in oral solid dosage forms manufacturing processes development and scale-up from bench top to pilot scale
Education on a Scientist, Formulation Resume
Make sure to make education a priority on your scientist, formulation resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your scientist, formulation experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Scientist, Formulation Resume
When listing skills on your scientist, formulation resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical scientist, formulation skills:
- Strong scientific background, attention to details, and good oral and written communication skills
- BS 8+ years of experience, MS 5+ years of experience or PhD 3+ years of experience in pharmaceutical dosage form development
- BS 8+ years of experience, MS 5+ years of experience or PhD 3+ years of experience, in pharmaceutical dosage form development
- Hands on experience in Pharmaceutical product development and GMP manufacturing preferably ANDA development and filing experience
- Work effectively as part of a team both within the formulation team and the wider multidisciplinary project team
- Working knowledge of methods and instrumentation used for the characterization of solution and solid-state properties of materials
List of Typical Experience For a Scientist, Formulation Resume
1
Experience For Scientist, Formulation Development Resume
- Self-motivated and capable of demonstrating technical competence and problem-solving skills
- Complies to EHS and GRP-standards and has solid JnJ Credo awareness acting accordingly
- Is skilled in pro-active identification of issues, problem-solving, and timely implementation of solutions
- Experience in pharmaceutical development and sterile drug product manufacturing
- Provide training and support, guidance and development for less experienced team members
- Perform complex sample preparation procedures such as large-scale buffer preparation and solid-phase extraction
- Solidknowledgein biologicsdrugproductdevelopmentandmanufacturingprocess isamust
- Capable of working independently in a fast-paced, team-oriented environment, demonstrating multitasking capabilities
2
Experience For Senior Scientist, Formulation Development Resume
- Provide technical assistance to manufacturing and quality operations for process troubleshooting
- Provides training and coaching of trainees and assistant/associate scientists
- Develops fit-for-purpose analytical methods to support formulation and process development and research stability testing
- Prepare technical reports, project monthly reports, PowerPoint presentations and other documentation reflecting the project(s) progress
- Troubleshoot manufacturing and quality control activities and record results in technical reports
- Actively participate in Practical Process Improvement (PPI) projects, including kaizen
- Adheres to timelines for performing experiments, and aligns with technicians
- Takes quick action through rapid learning cycles driven by scientific curiosity
- Utilize multiple analytical chemistry techniques, including MALDI mass spectroscopy, HPLC, HPIC, spectrophotometry, pH and conductivity meters, and titrations
3
Experience For Senior Scientist, Formulation Resume
- Manage manufacturing metrics aimed at process control and productivity savings
- Work as part of a team to design formulations and manufacturing processes for encapsulated drug products to meet the required target product profile
- Able to communicate well via written media with specific emphasis on report writing
- Participates in general lab and instrument maintenance
- Hands-on experience and trouble-shooting proficiency with chromatographic (HPLC, UPLC, column chromatography) and/or biophysical techniques (such as UV-vis, CD, FTIR, DSC, Fluorescence, NMR, x-ray crystallography, particle analysis, etc.)
- Detail oriented, be able to recognize subtle trends in data, and possess an ability to grasp the big picture
- Utilize statistical software to design and analyze Design of Experiments (DoE)
- Perform scale-up development and optimization of manufacturing processes for pharmaceutical products such as immediate release or extended release solid oral dosage forms based on current regulatory guidelines related to pharmaceutical development (such as ICH Q8, Q9 & Q10)
- Collaborate with Formulation & Process Design team regarding the design and execution of pilot and commercial manufacturing operations. This can include the creation of formulation sheets, master batch records, setting process parameters, batch execution, and post batch evaluation and analysis
4
Experience For Associate Scientist, Formulation Development Resume
- Ensures compliance with all aspects of cGMP’s
- Support Formulation & Process Design efforts, QbD, Scale up, Technical Service, Cleaning Validation, Process Validation, and Stability activities as mandated by cGMP’s policies/procedures and quality standards
- Evaluate retrospective quality by design (QbD) assessments of currently marketed products to improve quality, efficiency and mitigate potential cGMP and quality risk
- Thorough knowledge of pharmaceutical technology and pharmacy, chemistry and/or chemical engineering principles and applications
- Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside the Company
- Expertise in solid oral dosage form development and related manufacturing unit operations, specifically; blending, milling, wet/dry granulation, tableting, encapsulation and pan coating
- Demonstrated and applied knowledge of pharmaceutical manufacturing equipment, especially with respect to equipment and processes used to manufacture immediate release and extended-release oral solid oral dosage forms
5
Experience For Scientist Formulation Development Resume
- Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed during industrial process design, validation and control
- Execute formulation and process development activities using DOEs for new chemical entities or life cycle management opportunities
- Outsource/co-ordinate formulation development or clinical manufacturing at CROs/CMOs
- Ability/willingness to travel (domestic & international) to CMO partner sites up to 25%
- Propose new, innovative approaches for product development, discuss experimental designs and interpret data
- Carry out due diligence/paper feasibility on new product concepts
- Coordinate development activities with process chemistry, preformulation, analytical, and physical characterization groups
- Facilitate manufacturing, packaging and release of clinical supplies for clinical studies, assist in scale up activities at pilot and commercial scale, and summarize results in technical reports and presentations
6
Experience For Scientist, Formulation & Drug Delivery Resume
- Enhance Merck’s professional image and competitive advantage through patents, presentations, publications and professional activities and advance areas such as science and technology development, technical and business strategic improvements, business process innovations
- Stay abreast of relevant new and current technologies, capabilities, and effectively share this knowledge with others
- Independently designs, executes and documents stability studies and other experiments to support stability testing and understand quality attributes to support formulations and stability
- Presents work at group, department and cross functional meetings, serves as a team representative in drug development team meetings, and shares knowledge and expertise of formulations development at cross-functional team meetings
- Seeks out, recognizes and assesses new technologies to improve formulation development and stability testing
- Authors and reviews formulation development sections of regulatory and technical documents, study reports and technology transfer documents
- Experience in protein characterization, protein stability, analytical method development for biologics, protein formulation and other novel formulation development, such as nanoparticle formulation, are highly desirable
- Demonstrated track record of publications
7
Experience For Senior. / Scientist, Formulation Design Resume
- Able to quickly adapt to changes in project direction
- Prepare small scale formulations to support drug discovery and preclinical studies
- Take part in the design and execution of clinical formulation development studies for small molecule and peptide drugs
- Compile data, prepare summary presentation, and author technical reports
- Design, plan, carry out, and interpret laboratory experiments to properly characterize novel drug candidates (small molecules and/or peptides)
- Apply formulation and manufacturing principles, theories and techniques to product development and develop the best possible phase appropriate formulations and manufacturing processes
- Work closely with drug discovery teams to ensure timely and high-quality support for preclinical studies
- Author technical reports and CMC sections of the regulatory dossiers (INDs, IMPDs, and NDAs etc.)
8
Experience For Temp Scientist, Formulation Development Resume
- Represent Formulation on CMC teams and work collaboratively to ensure project progression, and communicate Formulation Development strategy and related challenges
- In collaboration with team members, design and execute formulation development strategies for Five Prime’s therapeutic proteins to support toxicology and various clinical studies and commercial launch
- Carry out lab experiments to generate study results to support the formulation development of the programs. These include design of study protocols, set up of the formulation screening/stability studies, manage the development stability programs and generate study reports
- Collaborate with colleagues in Analytical Development to define and apply analytical methods for the characterization and stability testing of the protein therapeutics. Maintain the lab instruments in good working conditions
- Participate in the interaction with CMO to support the fill-finish of GMP drug product for clinical supply. Prepare formulation report and technology transfer reports, participate in process transfer to CMOs for fill-finish of drug product, review manufacture batch records, and author documents for regulatory submissions
- Interact and coordinate with Analytical Development, Clinical Supply Chain, Clinical Development, and Project Leaders in defining product presentation, dosing requirements and product shelf life
- Stay current on state-of-the-art scientific knowledge and practice in biological drug product development. Innovatively integrate new technologies into the work stream within the company
- Ph. D in Biochemistry, Biochemical Engineering, Pharmaceutics Sciences, or related fields with 0-2 years of industry experience in biologic formulation development
- Good understanding of the biophysical and biochemical degradation pathways for protein therapeutics in liquid formulation
9
Experience For Temp-scientist, Formulation Development Resume
- Experience in common practices and procedures such as aseptic sample handling, stability program and stability pull, analytical method development and testing are required. Experience with SE-HPLC, iCE,IEX-HPLC,CE-SDS, DSC, light scattering, and HIAC particle counting are required
- Identify formulations matrices that ensure the stability of targeted biological and the adjuvant molecules in liquid and lyophilized vaccines
- Design and conduct formulation studies at various stages of development to provide data to support early phase clinical trial, such as stability, solubility and effects of pH
- Determine primary degradation pathways for biological and adjuvant molecules, including proteins adsorbed to alum and other adjuvants
- Develop appropriate assays to characterize the content and the purity of the biological and adjuvant molecules in the liquid and dry presentation
- Develop physiochemical and immunological methods required for formulation optimization and physicochemical characterization of a final drug product
10
Experience For Scientist Formulation Resume
- Perform statistical analysis of research data
- Manage in-house stability program
- Work closely with other groups within the Process and Analytical Development Department to characterize physical chemistry of proteins and the up/down stream bioprocesses.
- Propose and design novel delivery systems for parenteral administration
- Write internal reports, technical documentation and other appropriate documents as required
- Adequately and accurately document technical work in laboratory notebooks
- Work within internal and external quality systems to ensure documentation trails are maintained throughout
- Propose new, innovative approaches for product development, generate experimental designs, execute experimental plans and interpret data
- Formulation of both small molecules and biologics
List of Typical Skills For a Scientist, Formulation Resume
1
Skills For Scientist, Formulation Development Resume
- Experience in clinical formulation and manufacturing process development of oral solid dosage forms for small molecules and peptides
- Demonstrated ability in operating, troubleshooting, and maintaining complex laboratory equipment, including HPLC, HPIC, and MALDI mass spec
- Experience in conducting and managing drug product activities at CDMOs
- Specific experience with lyophilisation and analytical equipment (particle sizing, DSC, microscopy etc.)
- Work using own initiative, under pressure and demonstrate ability to manage multiple projects and timelines
2
Skills For Senior Scientist, Formulation Development Resume
- Experience in managing drug product activities at CMOs
- Current experience performing a variety of antibody based assays for bulk materials, in-process materials and finished products
- Experience developing formulations and processes
- PhD in chemistry, biology, pharmacy, engineering or related pharmaceutical science; 0+ years relevant industry experience
- Experience in developing formulations of vaccine and biologics for sterile parenteral administration in both pre-clinical and clinical studies also required
- Solid fundamental understanding of biopharmaceutical and physicochemical properties relevant to formulation design and development
- Experience in phase-appropriate drug product formulation development, manufacturing process development and process scale-up
- Experience in managing drug product activities at CDMOs
3
Skills For Senior Scientist, Formulation Resume
- Biopharmaceutical, Pharmaceutical or Medical Device industries including drug product development experience
- Experience performing early phase formulation/process development of a wide range of dosage forms for small molecule new chemical entities (NCEs)
- PhD in pharmaceutical sciences, chemical or biochemical engineering, chemistry or related scientific field with 5+ years of industrial experience
- Experience in drug product formulation, manufacturing process development and scale-up
- Strong fundamental understanding of physicochemical and biopharmaceutical properties and their importance in formulation design
4
Skills For Associate Scientist, Formulation Development Resume
- Writing and reviewing of appropriate technical MBR, SOPs for use both internally and at CMO and/or CROs
- Working knowledge of parenteral and non-parenteral formulations
- Understanding of GMP requirements
- Working knowledge and know-how to support preclinical studies with variety of formulation approaches and delivery routes
- Adhering to the relevant quality and regulatory standards
- Understanding and the ability to follow safety precautions and procedures which apply to the activities in the laboratory
- Ph.D. in Chemical Engineering, Industrial Engineering, Electrical Engineering, Computer Engineering or related discipline
- Revise and edit existing manufacturing protocols; participate in the development of manufacturing protocols for new products
- Ability and understanding in the selection of appropriate stability indicating techniques for evaluation of formulations
5
Skills For Scientist Formulation Development Resume
- Author and review drug product technical development reports and manufacturing/packaging batch records
- Maintains accurate and up to date records, including appropriate lab notebook recordings. Capable of achieving deliverables in a timely fashion
- Design & execute experiments employing quality by design (QbD) principles to develop robust formulations and manufacturing processes
- Support internal capability development by evaluating new technologies and deploying them to pipeline assets
- Assist with customer audits relating to own project issues covering R&D labs
- Comply with company policy during daily operation, ensure data integrity to support drafting regulatory documents
- Train co-workers in the proper use of instrumentation, manufacturing processes, and manufacturing software
6
Skills For Scientist, Formulation & Drug Delivery Resume
- Provide support to Manufacturing e.g. troubleshooting, process optimisation
- Ph.D. in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Material Science, or related disciplines
- Oversee and manage formulation and process development activities (Phase 1-3) at external laboratories and contract development and manufacturing organizations
- Design experiments to define process parameters for tablet manufacturing unit operations
- Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies
- Enthusiasm in science with a motivation of making contributions in a team environment
- Enthusiasm in science with a motivation for making contributions in a team environment is necessary
- Delivery of formulation design and development activities of sterile dosage forms, utilising your technical expertise at all stages of projects
- Maintain knowledge and understanding of relevant regulatory requirements for GLP, department SOPs and company safety and environmental policies
7
Skills For Senior. / Scientist, Formulation Design Resume
- Maintain technical notebooks ensuring completeness and timely signatures
- Perform technical review of regulatory filing documents in China
- Participates in DPD sub-teams, ensuring alignment with project needs through Technical Integrator
- Is accountable for proper recording of information and collection of the data and for review of experimental results
- Knowledge of cGMP in formulation and analytical laboratory activities
8
Skills For Temp Scientist, Formulation Development Resume
- Resource Management -Project management skills; ability to manage one’s time within individual, departmental, and corporate goals and timelines; management of internal external resources (vendors)
- Teamwork -- Ability to work well in highly cross functional team environment and across global line functions
- Communication Skills -Able to expresses one’s self clearly and concisely within team; documents issues and/or concerns concisely with colleagues; adjusts communication style as appropriate for the audience; timely and effectively communicates issues to supervisor; technical writing skills to support authorship of internal technical documents
- Resource Management -Ability to manage one’s time within individual, departmental, and corporate goals and timelines; management of internal and external resources (vendors)
- Hands on experience in pre-formulation work including measuring physical properties (e.g. pKa, partition coefficients, pH-solubility profiles, etc), selecting suitable excipients etc
- Hands on working experience in solubilising excipient selection
- Knowledge/experience in lyophilisation cycle optimisation/development
9
Skills For Temp-scientist, Formulation Development Resume
- Experience in the formulation of both small molecules and biologics
- Experience in pharmaceutical drug product formulation, pre-formulation and/or process development
- Take ownership of tasks and projects
- Support the analysis of data from studies, method development, or tech transfer activities, and author reports for submission to multiple parties, including regulatory agencies such as the FDA and EMA
- Support the Senior Scientist in overseeing programs conducted both in-house and at 3rd party vendors
- Support the preparation of protocols, technical reports, summaries, and quantitative analyses for distribution and/or presentation to project teams, and for inclusion in reports and regulatory agency submissions using appropriate statistical analyses
10
Skills For Scientist Formulation Resume
- Support the team leader in project development strategies and planning and execution of deliverables
- Perform buffer screening and formulation development activities of vaccines, conduct basic formulation, particle characterization analytics, and potency assays
- Design and execute or oversee studies performed in-house or by CTOs to improve product performance and maximize shelf life of product
- Maintain cell-culture, and perform cell-based bioassays
- Lead formulation design and process development at the I & D center focusing on but not limiting to the development of solid oral dosage forms including tablets, capsules and dry syrup
- Apply effectively existing manufacturing capabilities at the I & D center as well as introduce novel technologies to drive new product innovation with enhanced performance
- Possess knowledge and able to execute drug product prototyping workflow including API characterization, excipient selection and process development
- Be skilled in QRM/QbD concepts for product development so as to develop a robust quality product that adheres to Abbott quality systems and global/local regulatory requirements
- Support the technology transfer of drug product manufacturing from laboratory to third party CMOs including scale-up investigation and process validation
List of Typical Responsibilities For a Scientist, Formulation Resume
1
Responsibilities For Scientist, Formulation Development Resume
- Experience with process modeling, simulation and automation integration in the pharmaceutical and/or industrial manufacturing sector
- Experience working with regulated documents
- Experience in preparing technical documents and presentations
- Experience in phase-appropriate drug product formulation development and manufacturing process development
- Staring at computer screen
- Manufacturing of Magnetic Polymer particles in medium factory scale production facilities
- Liaise with project team members during planning and execution of manufacturing activities to ensure project deliverables are met within stipulated deadlines
2
Responsibilities For Senior Scientist, Formulation Development Resume
- Draft process development documents for engineering run, PPQ and clinical manufacturing
- Participate in deviation investigation during DP manufacturing activities
- Stay current with the scientific literature. Leverage existing knowledge appropriately, being mindful of potential patents
- Familiarity with laboratory and/or manufacturing techniques
- Support and ensure operational readiness of manufacturing equipment at I & D center through timely execution of maintenance and calibration activities
- Attendance and contribution at project meetings / client calls
3
Responsibilities For Senior Scientist, Formulation Resume
- Liaise with production department to ensure a smooth transfer of information and processes
- Write work plans and reports for assigned projects to defined timelines
- Analyse data and provide scientific explanations and insight for project work
- Complete assigned projects to defined timelines
- Ensure general lab area is maintained to a high standard
- Maintain a level of technical ability required to carry out the responsibilities of a Formulation Scientist
4
Responsibilities For Associate Scientist, Formulation Development Resume
- Follow GLP, SOP, safety and hazardous waste rules on a regular and consistent basis
- Address areas of non-compliance as appropriate
- Provide input to technical agreements as required
- Attend customer meetings on and off site as required
- Provide technical support of fill finish process of large molecule drug product at both internal and external sites including tech transfer, review of manufacturing documents, and continuous improvement of the process
- PhDor other advanceddegreeinPharmaceuticalSciences, Chemical Engineeringorarelatedfieldwithatleast 3yearsofexperience.CandidateswithMS degreeinarelatedfieldandatleast 6yearsofworkingexperiencewillalsobe considered
5
Responsibilities For Scientist Formulation Development Resume
- Designs experiments to reach these project targets. Accountable for accompanying documentation such as Study Plans and Study Reports
- Provides translation of scientific goals into actions to accomplish the targets or project needs
- Discusses problems and presents plans and data in the Science Meeting. Presents regularly during the Journal Club. Pro-active intellectual participation in DPD science meetings, fully engaged
- Ensures the availability of materials and equipment to perform experiments and justifies the purchase of new materials and equipment
- Optionally: line responsibility for assistant/associate scientists. Ensures safe and pleasant work environment with sufficient personal development. Empowers people to act with speed, agility, and accountability
6
Responsibilities For Scientist, Formulation & Drug Delivery Resume
- Lead multiple formulation/process/scale up development projects at various stages for solid, or semisolid, or parental dosage forms
- Prioritize and schedule work to ensure on-time delivery
- Relevant experience in viral vaccine, protein and conjugate, or biologics formulation development
- Operate robotics equipment, image analyzer, high speed centrifuge and other lab liquid handling equipment
- Challenges the status-quo; leads and adapts to change
- Value creation. Is responsible for innovation, conception of new ideas. Creates Intellectual Property. Is insight-driven to uncover unmet needs. Is able to write scientific publications and patents
- Presents on scientific meetings, conferences and courses (internal and external)
- Delivers assigned project deliverables with high quality, within budget and timelines
7
Responsibilities For Senior. / Scientist, Formulation Design Resume
- Is able to think and challenge beyond own expertise area
- Accurately and reliably manage inventory
- Work synergistically with peers from your own and other groups
- Adhere to ISO guidelines, USDA regulations, and Thermo Fisher Scientific quality policy
- Adopt a positive attitude which contributes to a healthy work environment
- Design and execute targeted DS and DP formulation studies to support formulation development of vaccine antigen candidates within Vaccine Research and Development (VRD). Vet plans with management and work with the appropriate lines to secure the needed analytical characterization support
- Perform relevant biophysical and particle characterization of the prepared formulations, using techniques such as micro-flow imaging (MFI), dynamic light scattering (DLS), and zeta potentials
- Satisfactorily completes all cGMP/GLP and safety training in compliance with departmental requirements. Where applicable, performs job responsibilities in compliance with cGMP/GLP and all other regulatory agency requirements
8
Responsibilities For Temp Scientist, Formulation Development Resume
- PhD with 0-3 years’ experience in Pharmaceutics, Biochemistry, Life Sciences or related science
- Have an ability to troubleshoot issues and interpret data in the context of project needs
- Guide more junior team members
- Plan, design, conduct and report relevant experiments/investigations to meet project timelines
- Analyse and report data accurately in a clear and concise manner, with conclusions and recommendations
- Compilation of customer/client protocols and project reports to a high standard where required
- Small scale manufacture of technical and clinical batches to GMP standards
9
Responsibilities For Temp-scientist, Formulation Development Resume
- Support process development and the transfer formulations to commercial manufacture
- Able to demonstrate previous success in R&D projects from concept to completion and understands the technical issues involved with drug development and preferably drug delivery
- Enhance our organization’s professional image and competitive advantage through patents, presentations, publications and professional activities and advance areas such as science and technology development, technical and business strategic improvements, business process innovations
- Familiarity and working knowledge of manufacturing processes and equipment set up, operation and troubleshooting for various pharmaceutical dosage forms
- Review analytical data, draft GMP manufacturing batch records/protocols, and product development reports
- Lead manufacturing investigations as required
- Perform literature/patent search for innovation product development and generic product development in supporting of regulatory submissions of INDs, NDAs, and ANDAs or patent filings. Apply Quality-by-Design (QbD) principles to product development
10
Responsibilities For Scientist Formulation Resume
- Experience with ISO-13485:2016 or 9001 and other regulatory standards
- Lab experience
- Familiar with validations and equipment IQOQ
- Experience in a ISO 13485 environment
- Experience in early stage formulation development for drug substance
- Assess and characterize physicochemical properties of drug substance to design phase appropriate pre-clinical and clinical solid and liquid formulations
- Proven ability to identify and develop innovative ideas
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