Drug Product Development Resume Sample
Elenor Bashirian
19953 Tito Turnpike,
Philadelphia,
PA
+1 (555) 868 4740
Work Experience
Senior Scientist, Drug Product Development
06/2017
-
PRESENT
Boston, MA
- Provide department-wide operations support including establishing more effective systems and processes, technical evaluation of new technologies and contract partners.
- Lifting and moving supplies and equipment (up to 25 pounds)
- In support of formulation and process development of the product portfolio, design relevant DOE’s and conduct statistical data analysis
- Ensure execution of the function’s risk assessment and escalate at relevant bodies. Development of mitigation plans
- MS with at least 10 years industry experience in Material Sciences, Chemical Engineering or Pharmaceutical Sciences or related Scientific discipline OR a PhD with at least 3 years industry experience in Material Sciences, Chemical Engineering or Pharmaceutical Sciences or related Scientific discipline is required
- Demonstrated proficiency in a variety of analytical instruments and software utilized for physical and chemical analysis is required
- Knowledgeable in evaluation of product contact material extractable and leachable compounds, including analytical characterization and toxicology assessments (such as ICP-MS, etc.) is required
- Familiarity with a variety of compendial references including United States Pharmacopeia is required
- Experience maintaining high quality documentation, analyze and properly interpret data, and prepare reports, SOPs or other technical reports is required
Scientist, Drug Product Development
07/2011
-
12/2016
Dallas, TX
- Fully integrated team member of the drug product development team supporting formulation and process development (currently managed at CMOs) including formulation design, data review and analysis, critical process parameter identification, stability study review and trending, process transfer, and batch record development and review
- Evaluate and develop drug delivery systems for parenteral and oral products in the pipeline as necessary
- Support/ Lead externally managed studies to characterize the product manufacturing process to determine critical process parameters and material attributes and their relationship to product quality attributes and process performance
- Support technical troubleshooting including deviation handling and investigations
- Contribute to CMC regulatory submissions
- Designing and optimizing various formulation and filling unit technical operations including freeze/thaw, mixing, sterile filtration, vial and syringe filling and lyophilization
- Participate in the execution of pilot to scale fill/finish manufacturing processes
- Design and manage non-GMP stability studies on experimental and target formulations
Drug Product Development Operations
05/2009
-
05/2011
Detroit, MI
- Perform studies that contribute to the continuous improvement manufacturing process, and administration equipment used to support clinical dosing
- Author technical reports and make presentations of technical data
- Follow general laboratory safety procedures, as related to biologically-derived materials
- Collaborate with contacts inside the company including functional line management as well as scientists in related functional areas such as Research and Development, QC/QA, Clinical, Manufacturing, Toxicology, and Regulatory (CMC)
- B.S. in an appropriate scientific discipline with at least 2 years of related laboratory experience OR an M.S. with at least 1 year laboratory experience is required
- Support buffer preparation for both GMP and non-GMP use with buffers prepared to GMP standards
- Together with scientific staff, develop standardized recipes and define appropriate release requirements for the prepared buffers demonstrating fit for use as GMP or non-GMP reagents
- Follow defined buffer preparation guidelines and protocols to ensure the prepared solution meet the quality and technical standard as required
- Properly maintain laboratory instrumentation needed to complete the buffer preparation process
Education
Shawnee State University
2003 - 2008
Science's Degree in Natural Science
Professional Skills
- Builds and maintains strong working relationship with CRO/CMO partners ensuring that activities are managed collaboratively, efficiently, and effectively
- Work well within cross-functional teams and provide leadership through effective communication skills
- Skillfully exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results
- Experience working in a GMP laboratory operating basic lab equipment (pH meter, balance, etc.)
- Experience analyzing samples using HPLC and UPLC methods
- Experience with scale up and technology transfer for pharmaceutical manufacturing
- Experience supporting buffer preparation to GMP standards
How to write Drug Product Development Resume
Drug Product Development role is responsible for travel, research, design, manufacturing, analysis, software, health, documentation, instrumentation, leadership.
To write great resume for drug product development job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Drug Product Development Resume
The section contact information is important in your drug product development 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 Drug Product Development Resume
The section work experience is an essential part of your drug product development 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 drug product development responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular drug product development position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Drug Product Development resume experience can include:
- Experience properly maintaining laboratory instrumentation needed to complete the buffer preparation process
- A background in biopharmaceutical manufacturing and experience and awareness of sterile liquid fill-finish (vials and syringes) would be a real advantage
- Experience running scale-up and scale-down experiments to support Formulation, Fill, and Finish operations of drug products
- Developing standardized recipes defining QC testing requirements
- Hands-on laboratory work, managing projects, and coordinating development activities with other drug product team members
- Ensure buffer preparation activities meet the safety requirements
Education on a Drug Product Development Resume
Make sure to make education a priority on your drug product development resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your drug product development 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 Drug Product Development Resume
When listing skills on your drug product development 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 drug product development skills:
- Possess excellent verbal and written communication skills and interpersonal skills, together with highly developed motivational and organizational skills
- Demonstrated communication and negotiation skills in English
- Strong hands-on instrumentation skills
- Effectively work, perform, and lead within a team of dedicated scientists is essential
- Think critically and creatively and effectively work independently and determine appropriate resources for resolution of problems
- Effectively work and perform within a team of dedicated scientists is essential
List of Typical Skills For a Drug Product Development Resume
1
Skills For Scientist, Drug Product Development Resume
- Good verbal/written communication skills and good documentation skills
- A good understanding of vaccine formulation science, freeze-drying technologies and key analytical assays is required
- Maintains preformulation instruments under good working conditions
- Supervisory or management experience in technical individuals or programs in different clinical phases
- Experience with implementation of state-of-the-art technologies and principles in the development of robust and marketable oral and parenteral dosage forms
- Requires conceptual and practical experience with the project management function
- Expertise in process mechanistic and statistic modelling for oral and parenteral dosage form development and manufacturing
- Expertise in chemometric modelling
- Expertise with designing DOE’s and statistical analysis
2
Skills For Senior Scientist, Drug Product Development Resume
- Undergraduate studies in a life science or related discipline such as biology, chemistry, biochemistry, bioengineering, pharmacy, and pharmaceutical sciences
- Design and execute or oversee studies performed in-house and at CMO’s to improve product performance and maximize shelf life
- Manage CMO’s for various aspects of FDP manufacturing including authoring and reviewing of Batch Records/Master Production Records specific to unit operations, reagent acquisition, raw material specifications, transfer of in-process analytical testing methods, and person-in-plant for GMP activities
- Master’s of Science in chemistry, biochemistry, biological engineering or closely related field with 5-10 years industry experience in pharma/biopharma or PhD in same field(s) with 2-5 years of same applicable industry experience
- Translate lab-scale data into viable manufacturing process parameters
- Provides direct on-site pharmaceutical sciences support to enable efficacy, PK, and toxicology studies for San Diego based discovery groups
- Provides drug substance physico-chemical characterization & offers solutions to enhance exposure in the preclinical species
- Supports compound nomination activities
3
Skills For Head of Large Molecule Drug Product Development Resume
- Experience in a cross-functional, global environment, where interactions with other, equally talented individuals requires technical expertise, negotiating skills and diplomacy
- Expertise in engineering process development, scale-up, and optimization
- Experience working within GMP environment, implementing and maintaining high quality standards for all aspects of the work conducted including adherence to regulatory, GMP compliance, departmental, and safety guidelines
- Familiar with root cause analysis methodologiesProcess Engineering
- Hands-on and in-depth understanding of different protein chemistry characterization and stabilization techniques, as well as pharmaceutics relevant to drug product development including lyophilized, liquid and suspension dosage form in vial
4
Skills For Expert Scientist, Drug Product Development Resume
- Good understanding of cGMP, pharmacopeia testing and regulatory requirements for filing and registration of vaccine and/or biologics with some knowledge of Quality by Design also desirable
- A thorough understanding of vaccine formulation science, freeze-drying technologies and key analytical assays is required
- Knowledge about physical characterization of the vaccine formulations using high-end instrumentation is required
- Relevant scientific discipline (e.g. Pharmaceutical Sciences, Chemical Engineering, Biochemistry)
- Experience with biophysical assessment techniques for bio-molecular characterization and stability evaluation, such as Spectroscopy techniques (UV/Vis, Fluorescence, FRET, Light Scattering, CD), DSC, ITC, SEC-HPLC, RP-HPLC, DLS, and particulates detection
5
Skills For Senior Manager, Drug Product Development, U.S Resume
- Demonstrated knowledge, experience, and successful track record in discovery and preclinical support, preclinical formulation development, salt screening and selection, polymorph screening, solid state characterization, and aiding FIH formulation design
- Experienced in enabling formulation technology to enhance oral exposure
- Thorough understanding of all aspects of the R&D process
- Knowledge of GMPs and CMC regulatory requirements concerning drug development
- Maintain in-depth knowledge of state-of-the-art principles and theories, applying such knowledge that supports the company’s goals
- Demonstrate technical proficiency, scientific creativity, collaboration with others, and independent thought in suggesting experimental design and research strategy
- Knowledge about physical characterization of the vaccine formulation using high-end instrumentation is required
6
Skills For Associate Scientist, Drug Product Development Resume
- Strong Scientific and/or Engineering knowledge of the drug product development process for solid oral dosages, drug delivery technologies and/ or combination products
- Knowledge of formulation development for small molecules to support oral, and potentially other dosage forms, drug products
- Maintain clear communication with scientific staff regarding buffer request, turnaround time, solution parameters (pH, reagent grade, etc.), and notification of completion
- Document buffer preparation procedure and testing results following required documentation guidelines
- Help execute laboratory studies, make detailed observations, analyze samples and interpret data
- Maintain documentation, author clear and user-friendly technical documents such as study protocols, and investigation reports
7
Skills For Senior Process Engineer Drug Product Development Resume
- Coordinate activities in small groups, and run scale-up and scale-down experiments to support Formulation, Fill, and Finish operations of drug products
- Present and clearly communicate results and technical analysis to technical and non-technical people within and outside of company
- Work independently, make critical project decision based on laboratory studies and investigation
- Experience with studying particle formation in various delivery systems including but not limited to controlled release, nanotechnology, encapsulation, long acting injectables
- Prepare documents for regulatory filings and internal company use. Design experiments and provide relevant data to support responses for FDA minor deficiency letters
- MS with at least 10 years relevant experience in Protein Chemistry, Chemistry, Chemical Engineering or Pharmaceutical Sciences or related Scientific discipline OR a PhD with at least 3 years relevant experience in Protein Chemistry, Chemistry, Chemical Engineering or Pharmaceutical Sciences or related Scientific discipline is required
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