Senior Scientist, Drug Product Manufacturing Technology

As a Senior Scientist, provides expert support for Drug Product Manufacturing Technologies (DPMT) and Operations. You will be a member of DPMT team supporting the development and launching of innovative drug products for fulfillment of patient needs.

What You Will Achieve

Provides technical support to Drug Product Manufacturing Technologies (DPMT) with focus on liquid, semisolid and pharma/biopharma sterile injectable dosage forms. Develops and validates manufacturing processes for drug products, including new or revised dosage forms or presentations. Leading tech transfer, scale-up activities, and late-stage drug product operations.

Conducts tests and measurements throughout the stages of production to determine control over applicable variables. Identifies and implements process and equipment efficiency, safety, quality and/or cost improvements. Supports Quality and Operations with investigation of deviations. Identifies and mitigates risks in development, validation, production, quality, and support operations that could negatively impact the safety, identity, strength, purity, and quality of the product.

Performs root-cause analysis and identifies appropriate, effective corrective and preventive actions. Implements corrective and preventive actions in conjunction with other enabling groups (i.e. Engineering, Maintenance, Quality, Validation, EHS). Works comfortably and interchangeably on the manufacturing floor, in lab, and/or office environments

How You Will Achieve It

• Applies extensive technical and industry-specific expertise and has full knowledge of the requirements of other related disciplines (technical, regulatory, QO, project management, etc).
• Leads quality and technical discussions with R&D, regulatory, operations, engineering, and quality teams regarding resolution of compliance related situations.
• Development and tech transfer of liquid, semisolid, sterile injectable dosage form development for pharma and biopharma drug products including medical devices and biologics.
• In-depth experience in late-stage drug product development activities such as sterile filter validation studies, extractable and leachable assessments, shipping validation studies, bulk freeze-thaw studies…etc.
• Experience in CPP(s) and CQA(s) assignments for drug product manufacturing process.
• Demonstrated skills in leading, planning, and developing successful technology development and implementation.
• Technical lead for product/process technology transfer from research, other sites, other areas with the site production
• Perform impact assessments for process deviations, material evaluations and provide justifications.
• Perform root cause analysis and identify appropriate Corrective Actions and Preventive Actions
• Ability to gather, analyze, interpret, relate, and compare information from multiple sources and identify cause and effect relationships.
• Implements new methods and processes to solve process related problems as assigned and identify and recommending their own work or projects. Able to adapt and respond positively to situations and people to meet changing work unit priorities.
• Design and execute Quality by Design (QbD) and Design of Experiment (DOE) principles in drug product and process development.
• Support process validation of new products and tech transfer projects. Create and/or review batch records, recipes and BOM(s)
• Primary author for reports, technical memo(s), process performance qualifications protocols presentations, reports, and technical papers with minimal direction.

Qualifications

Must-Have

• Applicant must have a high school diploma (or equivalent) and 8 years of relevant experience.
• OR an Associate’s degree with 6 years of experience.
• OR a Bachelor’s with at least 3 years of experience.
• OR master’s degree with more than 1 year of experience.
• Strong aptitude for learning process technology and equipment.
• Excellent written and oral communication skills.
• Demonstrated ability to interact effectively with all levels of the organization including diverse educational and cultural backgrounds.
• Flexibility and ability to embrace and lead chance.
• Ability to work in a high-paced team environment.

Nice-to-Have

• Experience in a cGMP environment including specific knowledge of and experience with drug product processing and equipment is desired.
• Good understanding of QbD approach and DOE designs.
• Experience in regulatory dossier submissions and response to queries.
• Through knowledge on validation practices and experience in manufacturing process verifications.
• UpToDate with new technologies and applying these techniques and methods where appropriate.

PHYSICAL/MENTAL REQUIREMENTS

• Frequent time in manufacturing, lab, and office environments.
• Must be able to perform gowning requirements for entry in the manufacturing areas.
• Requires lifting, sitting, standing, walking, stair climbing and roof access.

WORK ENVIRONMENT

• Office environment, with frequent time in the lab/manufacturing areas.
• Possible exposure to high noise environments, solvents, and pharmaceutical ingredients.
• Use of hearing and eye protection is required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• The focus of the work is at the Kalamazoo, MI site, however 0-20% travel may be required for network support.
• Must be available to support 24/7 – 365 operations.

Work Location Assignment:On Premise

Other Job Details:

• Last Date to Apply for Job: January 10, 2024
• Eligible for Relocation Package
• Eligible for Employee Referral Bonus

The annual base salary for this position ranges from $75,700.00 to $126,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits tendersglobal.net (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

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.

Engineering

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