EXPECT MORE FROM YOUR CAREER
PPD is a leading global contract research organization. At PPD we are passionate, deliberate, and driven by our purpose - to improve health.
PPD Laboratories offers the most comprehensive set of laboratory services available in the industry and continues to deliver innovative solutions to our clients through our collaborative approach, including PPD® Laboratories FSP.
PPD® Laboratories FSP is a unique partnership that allows our clients to leverage the experience of our PPD staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical / biopharmaceutical company, all while maintaining full-
time benefits / advantages of being a part of PPD.
As a Program / Project manager in this role you will be part of a Biologics Product Development team. You will provide scientific and administrative direction for the development and validation of bioanalytical methodology to support manufacture and development.
This position has accountability for technical decision-making. You will be a major contributor to the writing of technical development reports as well as regulatory submissions and will work with external CMOs / CROs as well as the client Quality and Regulatory organizations to ensure that their products meet the highest standards for quality and supply.
Manage contract method development. Oversee work flow, progress, and milestone achievements
Responsible for all aspects of technology transfer of analytical methods to the designated manufacturing group.
Ensure methods being developed represent commercially practical quality and process controls.
Define appropriate analytical methodology for quality and regulatory controls for Drug Substance, Drug Product, and critical intermediates.
Oversee method scouting, qualification and validation in accordance with appropriate regulatory requirements (FDA at a minimum, EMA a plus)
Design and manage appropriate stress and stability studies, and organize analysis and reporting of data
Ensure practices and procedures in GXP assays data analysis are GXP compliant.
Prepare, review, and revise SOP and test methods.
Write / review method development reports
Provide support to project teams and participate in strategies for product development and obtaining regulatory approval.
This position requires proven abilities and skills in leadership and working in cross-functional work teams.
Education and Experience
B.S. / B.A. in Chemistry, or related field with 4 years lab related experience in the pharmaceutical and / or biotech industries or
M.S. in Chemistry, or related field with 3 years lab related experience in the pharmaceutical and / or biotech industries
Ph.D. in Chemistry, or related field with 2 years lab related experience in the pharmaceutical and / or biotech industries
Including 1-2 years experience working with single or multiple lab studies to include the areas of stability, QC, and method development and validation
In some cases a combination of education and prior directly related experience may be considered as equivalent to the above requirements provided that the individual possesses the following knowledge, skills, and abilities to perform the job accountabilities satisfactorily.
Knowledge, Skills and Abilities
Knowledge and proficiency in analytical chemistry technologies associated with cGMP studies.
Experience managing contract analytical development for biologics
Experience in characterization of a variety of biologics by orthogonal methodologies as well as standard QC methodologies for different dosage forms (lyo, liquid, tablets, etc)
Experience in managing method development from Phase 1 to post-approval
Demonstrates technical proficiency, creativity, collaboration with others, and independent thought. Strong teamwork skills.
Excellent problem solving, judgment and decision-making skills.
Demonstrated proficiency in troubleshooting and problem solving and use of experimental design to elucidate effects of variables.
Effective oral and written communication skills.
Proven organizational and negotiation skills.
Understanding of basic budgeting and forecasting terms and definitions
Full understanding of cGMP requirements, ICH guidelines, USP requirements and FDA guidance
Ability to multi-task and effectively prioritize workload
Excellent computer skills
Possesses good interpersonal skills and positive attitude.
PPD is an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group.
North America-United States-Pennsylvania-FSP2 Philadelphia, PA