Manager - US Analytical Development

Role Summary

The qualified candidate will take an active role in leading Analytical Development of Sterile Injectable and Solid Oral Drug Products in the USA, and Extractables & Leachables work across two development centers at Lake Forest (USA) and at IITM Chennai (India).

Working with cross-functional development teams and external development organizations, the candidate will be responsible for the development and execution of analytical development strategies supporting the analytical activities and controls for drug products. The organization will be focused on the development and implementation of advanced analytical measurement and data analysis techniques in support of analytical method development and validation, drug degradation and stability testing, Extractables/Leachables (E&L) and structural elucidation of unknown compounds.

The candidate should be proficient with a breadth of analytical methodologies with expertise in one or more techniques. The candidate should also be proficient with a wide variety of software and information systems and have a demonstrated ability to learn new techniques and solve complex analytical problems. Experience with the use of digital tools and mathematical modeling is also desired.

The candidate will lead a group that is highly focused on the use and implementation of these skills to better understand our products and its interactions with components throughout the development lifecycle. This will be balanced with an ever-present desire to improve upon our capabilities and help develop cutting edge analytical and predictive capabilities.

ROLE RESPONSIBILITIES

Analytical Development USA:

• Develop analytical strategies in support of pharmaceutical drug products during all development phases, including supporting manufacturing process development, developing, validating and transferring analytical methods, designing stability studies to understand drug degradation mechanisms and for shelf-life assignments, and developing impurity control strategies.
• Demonstrate a strong understanding of GMP Controls, regulatory and CMC requirements.
• Plan, direct, and review the lab work of other scientists.
• Responsible for the review of analytical method validation protocols/reports and oversees the execution of the work at external labs.
• Collaborate with colleagues to identify appropriate analytical approaches, including use of computational predictive tools, modeling software and data visualization tools where appropriate.
• Critically review and interpret scientific data to derive clear conclusions and provide direction for future work.
• Author relevant sections of the quality modules of regulatory submissions.
• Provide day-to-day scientific and operational leadership to ensure that fit for purpose, robust, and cost-effective development of processes.
• Assist in setting strategic and scientific direction for group.
• Develop, design and perform experiments related to the implementation of measurement systems to our Drug Product processes.
• Create an environment that attracts, develops, retains, and promotes diverse scientific talent through challenging assignments aimed at advancing staff capabilities and in the end strengthening Pfizer's ability to execute on product development and commercialization commitments.
• Provide leadership and communicate clearly and concisely across multiple scientific and business functions, building effective relations with internal and external customers.
• Supervise and lead BS/MS/PhD laboratory scientists across two regions, including handling general administration responsibilities within respective areas of responsibility and handle functional management issues related to direct reports:
  • Merit Budget input
  • Performance Assessment/Rating input
  • Promotion recommendations
  • Job descriptions
  • Recognize and address skill gaps, including coaching on colleague Individual Development Plans.
  • Scientific Advancement
  • Employee Health and Safety

Extractables and Leachables (USA):

• Responsible for all Extractables and Leachables work for sterile injectables (SI) and anti-infectives (AI) Sterile Injectables.
• Lead efforts across two development centers located in the US and India.
• Develop of analytical concepts in support of Extractables and Leachables strategy
• Oversee the design and execution of studies to meet requirements in USP and .

BASIC QUALIFICATIONS

• Ph.D., MS or BS in Analytical Chemistry, Pharmaceutical Sciences, Physical Chemistry, Organic Chemistry, Material Science or Chemical Engineering with 5+ years (Ph.D.), 7+ years (MS), or 10+ years (BS) experience.
• Prior management experience of 3 or more years required.
• Very knowledgeable in at least one spectroscopic technique (e.g., chromatography, mass spectrometry, dissolution, spectroscopy, and NMR) with hands on experience in collecting data from solid or liquid samples.
• Conversant in Spectroscopic (LCMS, GCMS, NMR, ICP-MS) and Chromatographic (HPLC, prep LC, TLC) techniques.
• Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required.

PREFERRED QUALIFICATIONS

• Understanding of the impact of excipient variation on product quality, knowledge of polymeric materials used in pharmaceutical applications such as elastomeric closures, API material characterization technique familiarity, understanding of the current regulatory landscape for the pharmaceutical industry, familiarity with various guidance and standards that are utilized by the pharmaceutical industry, and finally familiarity with systems control principles.
• Experience in areas for both drug product and API.
• Familiarity with the eventual implementation area of commercial manufacturing operations would be highly desirable.
• Strong oral and written communication skills to effectively interact with leaders as part of a multi-disciplinary team.
• Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required.

NON-STANDARD WORK SCHEDULE, TRAVEL, OR ENVIRONMENTAL REQUIREMENTS

• May require travelling: 10 to 20% of the time

OTHER JOB DETAILS

Eligible for Employee Referral Bonus

Relocation Support Available

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

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