1+ months

Principal Scientist, Formulation Development

Pfizer
Andover, MA 01810
Principal Scientist- Formulation Development, is a position within the Pharmaceutical Research & Development (PhRD) department in Pfizer's Biotherapeutics Pharmaceutical Sciences organization. This scientific leadership role will be responsible for formulation development, investigating physico-chemical characterization methods, scale up and tech transfer of Pfizer's biotherapeutics portfolio which include various modalities such as gene therapy, nucleic acid delivery, monoclonal antibodies and antibody construct, proteins and vaccines. Candidate will be expected to work in a dynamic and highly interdisciplinary environment to support pre-clinical, clinical and commercial development. In addition, the candidate should be able to contribute formulation selection and characterization source documentation to support regulatory submissions. This position requires exceptional time management and communications skills with a strong attention to detail. A breadth of knowledge of analytical tools and techniques applied to materials science, colloidal structure and stability, process development and tech transfer approaches, nanotechnologies for formulation design, nucleic acid drug delivery and general pharmaceutical R&D is required.



**Responsibilities**

The incumbent candidate will be responsible for conducting experiments in support of developing, evaluating and characterizing formulations/processes, components and supporting delivery technologies for diverse therapeutic modalities including (but not limited to) mammalian and microbial fermentation derived candidate molecules, vaccines, plasmids, RNA-based medicines, peptides, and targeted delivery strategies. This individual function cooperatively with other members of the team to achieve the project goals. The incumbent displays technical awareness in various aspects of drug discovery and development, leads technical project team/s that will apply characterization and stability information to develop an appropriate dosage form to meet clinical and commercial needs, strong drive in learning new techniques and scientific commitment, and impactful scientific and technical contributions within the PhRD team and the respective project teams. Specific responsibilities include:



**Role Responsibilities**



+ Design, execute, and analyze experiments for existing and novel modalities. Define the appropriate parenteral dosage form, formulation, process design, scale up approaches, identify critical parameters, and define the design space

+ Support development of novel characterization techniques to characterize formulations to support process development and formulation design.

+ Lead experiments to confirm robust process performance across the control space. Compile experimental and analytical results, perform data interpretation, summarize, and report on data with conclusions and recommended next steps.

+ Provide technical representation and subject matter expertise (SME) in cross functional formulation, process and analytical investigations for commercial production processes.

+ Collect and share relevant academic literature, leverage external consultants/SMEs, and establish new collaborations with internal groups. Optimize current processes to ensure robust manufacturing of Pfizer's biotherapeutic portfolio.

+ Interface extensively in a matrixed environment with process and analytical development teams for process investigation support, assess new analytical technologies, support on-going process characterization and post-approval changes.

+ Maintain accountability for project success and results delivery.

+ Communicate research and development findings internally and externally.



**Qualifications**



+ M.S. with 8 or more years of industrial experience, or B.S. with 10 or more years of industrial experience in Pharmacy, Pharmaceutics, Analytical Chemistry, Biophysics, Biomedical Eng, Chemical Eng, Biochemistry, Biotechnology, Virology, Biology or equivalent scientific field.

+ Solid foundation in Formulation, analytical, chemistry, material science, and/or nano-particle technologies.

+ Experience in formulation development, pharmaceutics, pharmacy or drug product manufacturing or scale-up of biotherapeutics modalities.

+ Experience with various biophysical and light scattering techniques (DLS, NTA, Coulter Counter, etc.).

+ Experience with regulatory filings and submissions.

+ Effective communication skills and the ability to write detailed technical reports.

+ Exceptional organizational, communication, and critical thinking skills, and the ability to thrive in an interdependent and idea-rich environment.

+ Strong work ethic and attention to detail.



**Preferred Qualifications**



+ PhD with 4 or more years industrial experience in biotherapeutics formulation and process development.

+ Expert understanding and leadership of technical area necessary for biotherapeutic molecule formulation development.

+ Experience in designing parenteral dosage forms for biotherapeutics modalities including protein based, gene therapy, vaccines or nanoparticle delivery systems.

+ Experience in nucleic acid drug development (DNA, RNA, oligonucleotides).

+ Excellent leadership skills.

+ Experience in scale-up and technology transfer of aseptic processes to pilot/commercial scale manufacturing facilities.

+ Solid understanding of thermodynamics and kinetics.

+ Working knowledge of GLP/GMP requirements.

+ Experience in authoring regulatory submissions (IND, IMPD, BLA, MAA).

+ Solid understanding of QbD concept in design, execution, and interpretation of formulation and process development experiments.

+ Ability to demonstrate autonomy in representing functional area.



**Additional Job Information**



+ Last Date to Apply for Job: February 12, 2021

+ Eligible for Employee Referral Bonus

+ Eligible for Relocation



\#LI-PFE



**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.



**EEO & Employment Eligibility**

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.



Research and Development

Categories

Posted: 2021-02-01 Expires: 2021-06-05

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Principal Scientist, Formulation Development

Pfizer
Andover, MA 01810

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast