Sign In
 [New User? Sign Up]
Mobile Version

Sr Manager BASG


Andover, MA
Apply on the Company Site
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

Job Details

**Role Summary** Provide technical leadership for biosimilar, biological, large molecule projects, to help deliver the biologics portfolio for Pfizer. Please note this position may be located at any BASG site globally. **Role Responsibilities**

New Products

+ Lead cross-functional matrix Co-Development Teams working closely with PEH R&D, PIH R&D, PGS plants, Program Team, Asset Team and Business Units, to evaluate technology and processes to transfer, validate, and submit CMC modules, gain approval, and launch new biological/ large molecule products and/or support post approval major product enhancements of marketed products (i.e. new devices / formulations, line extensions) with a focus on the PEH portfolio - primarily biosimilars.

+ Develop and deliver Co-Development Plan for endorsement (includes key strategies for Ph3 readiness, Process Understanding / RFT, ICH / PV, and BLA/MAA filing).

+ Responsible for project budgets and reporting to Asset Team and associated Business Unit.

+ Represent BioTx PS (& Biosimilars PS) / PGS to Asset Team and Business Unit for new products.

+ Provides strategic direction to the teams based on input from the key stakeholders (BMT / R&D, Business Units, Asset Teams, PGS Sites) and drives alignment across stakeholders.

+ Engage contract manufacturers participating in key activities ensuring Pfizer's strategy is understood and resources are in place to support execution.

+ Identify issues related to new products requiring decisions and/or actions by management (i.e. BMT / BU governance, funding processes, planning / proposals for Decision Points).

+ Work with Regulatory, BioTx PS (& Biosimilars PS), PGS sites, and center groups to develop RegCMC Strategy and Key Messages, and execute strategies for filing, defending (query response), and launching new products

+ Responsible to ensure the appropriate Control Strategy is in place and endorsed by BMT, including delivery of initial technology life cycle plan to the Product Technology Team post launch.

Marketed Products

+ Lead Product Technology Team, cross functional team across all manufacturing sites (internal and CMOs), operations, technology groups (Site Tech Services, MSAT, BioTx PS (& Biosimilars PS)), and enabling groups (RegCMC, QO, etc.)

+ Develop ("Refresh") / Own Technology Lifecycle Plan for product (including analytics, DS, DP, and stability).

+ Drive alignment across stakeholders on technical strategies and priorities identified in Technology Lifecycle Plan.

+ Responsible for effective execution of technical projects driven by CIPs, transfers, troubleshooting, E2E assessment, etc.

+ Responsible for effective execution of product robustness program and knowledge management (i.e. PUP) in parallel in other projects.

+ Responsible for project resource plans / budgets and reporting to appropriate stakeholders (i.e. PPL, MSAT/BASG-LT, etc.).

+ Responsible to ensure that appropriate process control strategy is in place across unit operations (including trending, review, and action plans - as needed).

+ Act as linkage from Technology Team to ongoing product enhancement initiatives (e.g. new DP formulation, 2nd generation process).

+ Provide technical leadership to sites and contract manufacturers in the resolution of major technical issues, including identification and utilization of SMEs as needed.

+ Provide appropriate communication on technical strategies / Technology Team initiatives across broad network of stakeholders, including major changes that impact multiple sites and require effective coordination.

+ Active member of Product Team representing Technology Team.

+ Active member of Virtual Site Operating Team (VSOT) representing GTS for products manufactured at CMO.

Project Management/Leadership

+ Individual contributor role. Ability / skilled to effectively lead and execute within a matrix organization is very important.

+ Ability to effectively manage project budgets; Provide / support business justifications for project endorsement and/or prioritization evaluations.

+ Ability to effectively work in ambiguity and drive decision making in environment of competing priorities.

+ Experience working with PGS sites / operations, as well as enabling functions (i.e. QO, GCMC, WRS, VRD, BioTxPS, etc.), managing and leading projects to meet agreed deadlines, including regulatory submissions to support new products or CIPs.

+ Act as leader and contact point for projects that are not related to any particular site.

Lead by example matrix teams for challenging projects (i.e. complex, ambiguous, and changing landscapes - regulatory, technology, resources priority, etc.)


+ Minimum of BS degree in Bio / Chemical Engineering, Biochemistry, Biology or other science related field.

+ Minimum of 9 years in production, or product development (depending on degree).

+ Extensive technical and industry-specific expertise in areas of production of a biopharmaceuticals and/or vaccines.

+ Understanding of biosimilar / biological CMC requirements.

+ Understanding of commercial manufacturing requirements and operations.

+ Understanding / experience with Pfizer budget processes is preferred.

+ Familiarity with process of developing drugs

+ Demonstrated ability to effectively lead matrix teams.

+ Demonstrated ability to interact effectively with colleagues at all levels of the organization, including senior internal and/or external personnel on matters often requiring coordination between organizations.

+ Effective written and verbal communication skills.

+ Flexible and adaptable to changing priorities, meeting deadlines, and working well under pressure.

+ Ability to develop solutions to complex problems which requires the use of ingenuity, innovation, and creativity.

+ Experience in project management - ensuring successful completion of major programs / projects as part of a team and/or project leadership role.

+ Capable of working independently and on multiple products in parallel.

+ Strong PC skills required.

+ Willingness to travel; Ability to work with different cultures.


20% travel

**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.

**Other Job Details:**

+ **Last Date to Apply for Job: 12/18/2017**

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Apply on the Company Site
Powered ByLogo

Featured Jobs[ View All ]

Featured Employers [ View All ]