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Manager Stability


Kalamazoo, MI
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Job Details

Job Title Manager Stability

JobID 1610447

Location: Kalamazoo, MI

Description This posting is for a Manager position on the SLS Stability Administration team. The incumbent will be responsible for independently managing stability lifecycle (protocols, reports, change control) for assigned drug products and active pharmaceutical ingredients. The Manager will work on project teams for assigned products, ensuring all stability requirements are addressed, and may also represent the team on non-product specific projects both internal and external to SLS. The Manager will have responsibilities to represent stability with SLS customer groups and serve as the contact for routine meetings with the customer sites.

The Manager may also serve as an Subject Matter Expert for the Protocol and/or Report writing functions, authoring procedures, training tools, and job aids. The Manger may also work with the Manager/TL to address audit activities.

Administration activities include ensuring that appropriate stability protocols are designed, written and executed to comply with applicable internal, US and Worldwide regulatory requirements. The role requires regular communication with customers to identify study requirements and convey pertinent information about data availability. The incumbent must have strong teamwork skills, demonstrate resourcefulness in locating and evaluating data and other pertinent information, and be accountable for the accuracy and completeness of the work. The role has responsibilities to interface with laboratory personnel, Quality Assurance and project teams both within SLS and across many PGS sites. The incumbent must also demonstrate ability to work within a team to establish procedures and standard practices.

The incumbent:

+ serves as single point-of-contact for stability lifecycle management on assigned products. This includes the research and authoring of stability protocols, regulatory documentation, reports, change controls, and regression analysis;

+ works with stability operations personnel and technicians to ensure LIMS studies are set-up in accordance with approved protocols;

+ independently researches the necessary databases (e.g. LIMS) and other sources for information related to the stability performance of the product and assembles stability reports for regulatory submission;

+ communicates regularly with customers to identify study requirements, tracks timelines to ensure data are ready for submission and reporting, and conveys pertinent information about data availability;

+ participates in or manages change control activities for stability changes;

+ performs peer review of other team members work; provides mentorship to peers and technicians as assigned;

+ may serve as the subject matter expert (SME) for protocol and/or report authoring (procedures, job aids, training activities, audits)

+ leads meetings and represents the group within SLS and QO on project teams as needed; supports investigations, audits and regulatory queries.


B.S. Degree or higher in Chemistry or a related discipline.

Experience: minimum of 10 years of related experience in the pharmaceutical industry in stability or quality assurance role. This experience should include authoring of technical documents for regulatory or quality assurance purposes. Preferred experience with regulatory affairs, regulatory changes, compliance documentation.

The candidate shall demonstrate these skills:

+ strong oral and written communication skills

+ critical thinking skills and attention to detail and accuracy

+ knowledge of GMPs and regulatory (e.g. ICH) guidelines

+ knowledge of statistics and regression analysis

+ mastery of core computer software/systems (Word, Excel, Internet Explorer, PDOCS etc.)

+ ability to work in a team environment and manage projects independently

+ ability to lead projects

Preferred skills include:

+ Working knowledge of LIMS

+ Familiarity with information systems such as GDMS, SAP and QTS.

**EEO Statement**

**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.

**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.

**Additional Offer Details:**

+ **Last Date to Apply for Job: August 24, 2017**

+ **Grade: 10**

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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