Pfizer

Senior Scientist, Formulations, Drug Product Design

Employer
Pfizer
Location
Groton, Connecticut
Salary
Competitive
Posted
July 23 2021
Ref
4813281
Position Type
Full Time
Organization Type
Pharma
Job Type
Senior Scientist
ROLE SUMMARY
The primary role responsibility of a Formulation Senior Scientist is to provide drug product formulation and manufacturing process design expertise to deliver the R & D portfolio, including hands-on support for end-to-end dosage form design and development activities. Responsible for early clinical through commercial formulation and manufacturing process design of pharmaceutical oral dosage forms (both immediate and modified release) for new drug candidates and product enhancement programs. May serve as Drug Product Lead on matrix Project Teams and must be a strong team player with excellent communication skills working in a complex cross-functional matrix. The role requires knowledge of pharmaceutical, materials science, physical chemistry and engineering principles as applied to the design of solid dosage forms, biopharmaceutics, and advancement of drug delivery platforms for immediate and modified release.

ROLE RESPONSIBILITIES
  • Leverages strong understanding of chemistry, pharmaceutics, biopharmaceutics, engineering and/or materials science fundamentals to the design and development of immediate and modified release formulations and process understanding.
  • Maintains an awareness of and contributes to current scientific literature. Leads or supports departmental technology and continuous improvement initiatives. Actively applies new concepts as appropriate.
  • Designs and executes laboratory and computational experiments to support novel solid oral drug delivery platforms, initiatives, and portfolio-driven projects.
  • Utilizes appropriate predictive models and computational approaches to understand mechanical and physico-chemical characteristics of pharmaceutical compounds and formulations to assess performance and drive team decisions.
  • Ensures the chemical and physical stability of dosage forms by collaborating with materials scientists analytical chemists to achieve desired performance attributes and design the appropriate stability assessments to achieve a stable product.
  • Collaborates with cross-disciplinary teams and ability to partner with global, cross disciplinary subject matter experts in Pharmaceutical Sciences (Chemical Research &; Development; Analytical Research &; Development), Pharmacokinetics & Drug Metabolism, Clinical Pharmacology, Regulatory/CMC and Pfizer Global Supply (clinical and commercial drug product manufacturing)
  • Generates and interprets data from biopharmaceutics modeling tools, physicochemical (solubility, precipitation, & dissolution) and biological (passive, transporter mediated, efflux) transport phenomena, and pre-clinical and clinical pharmacokinetic studies to influence drug product development.
  • Authors and provides guidance to authors of regulatory documents supporting drug product development, including relevant drug product sections of IND submissions and CTD applications and associated queries to regulatory agencies.
  • Strong organizational, interpersonal, written, and verbal communication skills.
  • Effectively mentors other scientists.
  • Strives to grow scientifically and influence both the external and internal environment.


BASIC QUALIFICATIONS
  • BS + 8 years experience, MS + 5 years experience, or PhD in Pharmaceutics, Pharmaceutical Sciences, Chemistry, Physical Chemistry, Chemical Engineering, Biomedical Engineering, or allied disciplines
  • Excellent verbal and written communication skills.
  • Strong technical writing skills
  • Successful and efficient multitasking and working on a few projects concurrently
  • Detail-oriented


PREFERRED QUALIFICATIONS
  • PhD in Pharmaceutics, Pharmaceutical Sciences, Physical Chemistry, Chemical Engineering + 2 years experience
  • Proven ability to apply the principles of the basic sciences, such as physical and organic chemistry, thermodynamics, and materials science, to pre-formulation and formulation development, using a rational, scientific approach
  • Proven ability to use innovative approaches to the design of experiments for hypothesis-driven research.
  • Experience using contemporary computational approaches to predict the properties and performance of pharmaceutical drug product performance or guide process development
  • Sound knowledge of pharmaceutical and engineering principles in the solid dosage form development for both clinical and commercial scales
  • Hands-on experience with formulation techniques, processing equipment, and unit operations at both the laboratory and clinical manufacturing scales.
  • Experience with formulation development of modified release dosage forms.
  • Strong data analysis skills
  • A history of success working in environments defined by innovation and initiative
  • Ability to work effectively and comfortably in a multi-disciplinary team under defined timelines
  • Excellent leadership, teamwork and organizational skills
  • Solid verbal and written communication skills


PHYSICAL/MENTAL REQUIREMENTS

Includes activities in both laboratory and office settings; approximately 50% time in each of these settings. Some lifting in the laboratory. Ability to perform mathematical calculations and ability to perform complex data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

The position may require 10-15% travel to project meetings and support clinical, registration and validation campaigns at manufacturing sites.

Other Job Details:
  • Last Date to Apply for Job: July 30, 2021
  • Eligible for Relocation Package
  • Eligible for Employee Referral Bonus


#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

Similar jobs

Similar jobs