Senior Scientist – Lyophilization Process & Formulation Development

Employer
Pfizer
Location
St. Louis, Missouri
Posted
Oct 08, 2021
Ref
4824682
Required Education
Doctorate/PHD/MD
Position Type
Full time
Why Patients Need You

Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best in class medicines to patients around the world.

ROLE SUMMARY

This position will be part of the Biotherapeutics Pharmaceutical Research and Development group located in Chesterfield, MO (St. Louis area). The candidate will serve as a subject matter expert in lyophilization process and formulation design and optimization. As part of this role, they will lead the development, scale-up and transfer of lyophilized parenteral formulations and manufacturing processes from pre-clinical studies through to commercialization. Leadership responsibilities may include personnel supervision, project management, and/or oversight of laboratory activities. The candidate should be active in advancing the science and engineering of lyophilization and alternative drying technologies.

ROLE RESPONSIBILITIES

  • Develop lyophilization (freeze-drying) processes and lyophilized formulations for biotherapeutics
  • Scale-up from the laboratory to full-scale cGMP production
  • Utilize product characterization techniques and stability information to develop an appropriate dosage form to meet clinical and commercial needs.
  • Mentor and train other colleagues
  • Pursue innovations in lyophilization, formulation, and alternative drying technologies
  • Participate in management of the laboratory including safety, efficient operation and coordination of equipment purchasing and maintenance
  • Influences other groups within the company – can devise and explain strategy, concepts and complex technology to experts and non-experts alike.
  • Builds effective relationships with cross-functional Pfizer customers (e.g., listening skills, demonstrates empathy, conflict resolution).
  • Benchmarks and stays current with external publications, conferences or meetings.
  • Scientific contributions recognized outside of Pharmaceutical Research and Development; increased external influence (e.g,. publication, consortium, regulatory influence.

BASIC QUALIFICATIONS

  • B.S. in Chemical or Biochemical Engineering, Pharmaceutical Sciences or a related field, and 8+ years industry or equivalent experience.
  • M.S. in Chemical or Biochemical Engineering, Pharmaceutical Sciences or a related field, and 6+ years industry or equivalent experience.
  • Ph.D. in Chemical or Biochemical Engineering, Pharmaceutical Sciences or a related field.

PREFERRED QUALIFICATIONS

  • Familiar with lyophilized product characterization methods including differential scanning calorimetry, freeze-drying microscopy, moisture measurement, crystallinity characterization, dynamic vapor sorption and surface area measurement.
  • Excellent leadership skills
  • Expert understanding and leadership of lyophilization process and formulation development for biotherapeutics.
  • Experience in scale-up and technology transfer of aseptic manufacturing processes, including lyophilization, to pilot/commercial scale manufacturing facilities
  • Solid understanding of thermodynamics and kinetics
  • Working knowledge of cGMP 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.
  • Communicates well in written form and verbally across functional areas and large groups.
  • Solid understand of heat and mass transfer principles
  • Mathematical modeling experience
  • Understanding of cGMP manufacturing of sterile injectable products

Other Job Details:

  • Last Date to Apply for Job: November 1, 2021
  • Eligible for Employee Referral Bonus: YES
  • Eligible for Relocation Assistance: YES

#LI-PFE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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

#LI-PFE