PSSM Analytical R&D - Head of API Analytical Development

Head of Groton Project Analytics - API Analytical Development.   This group is responsible for all analytical aspects of API development (batch and continuous) from early workflows through to registration and technology transfer to PGS.  The group consists of approximately 40 colleagues spanning R1 thru R8 and Director level career ladders.

ROLE RESPONSIBILITIES

• Define strategic direction for the group and influence ARD strategy as a member of the global ARD Leadership Team.
• All aspects of API analytical method development to support API chemistry development, in process controls, raw material, intermediate and finished API testing.
• Development of material specifications based on safety and efficacy
• Overall impurity control strategy, inclusive of mutagenic impurity control and trace level analytical methods as needed
• Analytical method transfers to PGS and external vendors as needed
• Analytical sections of regulatory filings (CTDs, INDs etc)
• Identification, development, and adoption of new technologies to ensure discipline excellence and industry leading capability and value.
• Ensure all laboratory operations (training, equipment, data generation, documentation, and review) are in accordance with appropriate safety and quality procedures and best practices.
• Influence internally and externally as an industry leader in the Analytical Science discipline
• In conjunction with the ARDLT, develop and execute plans for identifying/procuring or developing key technical skills in thegroup for current and future needs through active workforce planning.
• Ensuring an engaged workforce built around a culture of scientific excellence, transparency, and integrity.
• Building and maintaining excellent partnerships with other global ARD groups and with leaders of key partners including Chemical R&D, PGS,  GCMC,  and Medicinal Chemistry

BASIC QUALIFICATIONS

• PhD or equivalent in Analytical Chemistry or related Pharmaceutical Science discipline
• 15 years’ experience in the Pharmaceutical Industry with significant knowledge of analytical chemistry and its application towards pharmaceutical development
• Knowledge of GMP as it relates to laboratory operations
• Well versed on ICH and other regulatory guidance with understanding of impact on analytical development
• Knowledge of Pharmaceutical Sciences and overall product development

PREFERRED QUALIFICATIONS

• Demonstrated ability in development of colleagues
• Outstanding collaborative skills
• Regulatory filing experience
• Track record of technology development
• Track record of influencing the external environment
• Experience with continuous manufacturing

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

This position may require travel to other Pfizer sites, vendors and partners with travel estimated around 10% of time.  Some travel may be international.

OTHER INFORMATION

• Relocation eligible
• Eligible for employee referral bonus

ORGANIZATIONAL RELATIONSHIPS

Pfizer Global Supply, Medicinal Chemistry, GCMC,  Drug Product Development, Drug Product Supply, Chemical R&D-Labs, CRD-Manufacturing

RESOURCES MANAGED

Financial Accountability

This role will oversee 40+ colleagues with a budget of approx. 5-7 million annually.

Supervision

Expected size of organization:  40+ colleagues

Expected number of direct reports:  6-8

Group may include additional contingent workers, as needed

Work Location Assignment: On Premise

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.

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

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