Senior Scientist, Drug Product Design and Administration
Senior Scientist- Drug Product Design and Administration is a position within the Drug Product Design and Development (DPDD) group, part of the Pharmaceutical Research & Development (PhRD) department in Pfizer’s Biotherapeutics Pharmaceutical Sciences organization. The incumbent will be responsible for developing drug product dosage forms, devising strategies for dosing parenteral therapies for Pfizer’s biotherapeutics portfolio, leading instructions for use development in the clinic and commercial use, labeling, and serving as an effective interface between various development functions.
- The incumbent will act as the interface for early clinical development between PhRD, Global Clinical Supply (GCS), and Clinical as well as an interface between Pharm Sci, Pfizer Global Supply (PGS), and the Research, Commercial, and Business Units to enable a drug product profile which supports a final product suitable for the patient as well as their disease.
- Recognized as a technical expert with growing scientific contributions.
- Providing subject matter expertise in all areas of drug product design, dosage preparation, administration, and instructional training working collaboratively with GCS
- Ensure all stakeholders are involved in decision making related to drug product profile development, product use instructions, labeling, packaging, and launch planning
- Understand and evaluate regulatory and quality requirements on dose preparation and connect those to devise strategies for biotherapeutics pipeline products
- Serve as a bridge between medical device compliance team and project teams to provide perspective from user needs and risks
- The Scientist must be able to interact effectively with a multidisciplinary team of scientists across departments/groups for the overall clinical and commercial development of the overall pipeline.
- Work cross-portfolio to develop solutions to challenges affecting multiple projects
- Communicate research and development findings internally and externally.
- Effective communication skills are desirable for interactions with laboratory scientists, project managers and colleagues from numerous functions, serving on multi-disciplinary project teams.
- Internal and External influence in Drug Product Handling topics
- PhD/Pharm. D. or other advanced degrees in Pharmacy with 0-3 years of experience, MS. in Pharmaceutical Sciences, Pharmacy, or equivalent scientific field with 7 years related experience (or BS with 9+ years of experience).
- Experience in Laboratory/Clinical/Pharmacy setting and with a variety of laboratory techniques is required.
- Ability to follow established procedures independently is required.
- Demonstrated scientific documentation skills.
- Familiarity with dosing and administration techniques
- Experience with the development of in-use stability studies, authoring of pharmacy preparation instructions, and regulatory requirements for in-use stability
- Experience in Biologic Drug Product development (fellowship, internship)
- Experience with clinical trials in a pharmacy context
- Excellent documentation skills.
- Self-motivated and highly effective in a team-based environment.
- Excellent communication and interpersonal skills, able to work at the interface of many different functional areas and ensure all viewpoints are considered
Other Job Details
- Last Date to Apply for Job: October 25, 2021
- Eligible for Employee Referral Bonus:
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