Senior Scientist- Drug Product Design, Formulations
A career at Pfizer offers opportunity, ownership and impact.
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
This position resides in the Process Development group within Drug Product Design. The primary responsibility is to provide drug product formulation and manufacturing process design expertise in order to deliver the R & D portfolio, including hands-on support for dosage form development activities. Responsible for commercial formulation and manufacturing process design of pharmaceutical oral dosage forms for new drug candidates using standard batch processing as well as the Portable, Continuous, Miniature, & Modular (PCM&M) development and manufacturing paradigm. May serve as Drug Product Lead on matrix Pharm Sci Project Teams, and lead appropriate Drug Product Sub-Team activities. Additional responsibilities may include leading or supporting departmental initiatives such as new technology development and continuous improvement projects. Interfaces with other departments on projects and represents the organization to external groups.
- Applies cutting edge process engineering tools to solve complex problems that arise during drug product development using conventional or continuous drug product manufacturing processes.
- Develop and implement advanced process models and process control algorithms for continuous drug product manufacturing processes.
- Collaborate with analytical colleagues in the development and application of Process Analytical Technologies (PAT).
- Utilizes technical experience, fundamental scientific knowledge and agreed Best Practices in formulation design and process development of pharmaceutical dosage forms for predominantly small molecules in the Pfizer R&D portfolio. Provides laboratory support as needed for project progression.
- Utilizes appropriate predictive models and Science of Scale approaches to understand mechanical and physico-chemical characteristics of pharmaceutical compounds and formulations/process to drive decisions and assess drug product performance.
- Capture key knowledge and formulation design/process development activities and learning in technical reports and shares with the Pfizer pharmaceutical development community.
- Collaborate with other groups within the department in order to define and implement commercial dosage form design and development strategies consistent with project timelines.
- Lead drug product development activities (pre and post-registration) and technology transfer to the commercial sites. If needed, provide on-site support for manufacture of clinical, registration and validation campaigns.
- Represent the department at the divisional level and provide recommendations to the partner lines and/or cross-functional teams.
- Author relevant regulatory submission documentation to support global filings. Collaborate with regulatory-CMC colleagues and provide continual post-filing support including PAI and regulatory query responses from various agencies.
- Maintains an awareness of and contributes to current scientific literature; actively applies new concepts as appropriate.
- Additional responsibilities include leading or supporting departmental initiatives such as new technology development and continuous improvement projects.
MINIMUM: BS 8 years' experience, MS 5 years' experience, or PhD in Pharmaceutics, Chemistry, Biochemistry, Chemical Engineering, Biomedical Engineering or Biophysics
DESIRABLE: PhD with 0 to 4 years' experience in Pharmaceutics, Chemistry, Biochemistry, Chemical Engineering, Biomedical Engineering or Biophysics preferred
- Experience in pharmaceutical dosage form development, technology transfer and a strong desire to design, execute (hands-on), analyze and interpret laboratory experiments related to drug product development.
- Demonstrated knowledge about the three pillars of drug development - biopharmaceutics, stability and manufacturability.
- Broad technical knowledge and experience with issues related to the design and development of pharmaceutical dosage forms, related scientific problem solving, and regulatory strategy and documentation.
- Strong organizational skills, interpersonal, written, and verbal communication skills.
- Solid scientific understanding of physical pharmacy and general pharmaceutics applicable to dosage form design and engineering principles relevant to manufacturing process development.
- Strong scientific leadership and direction of new technology initiatives.
- Established record of scientific achievement (publications, patents) is a plus.
- Candidate should be able to work effectively as part of cross-functional teams and embrace team work.
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.
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.
Additional Offer Details:
Last Date to Apply for Job: November 17, 2017
This job is Pfizer Exempt US Grade: 8
Eligible for Relocation Package
Eligible for Employee Referral Bonus