Pfizer Senior Manager/TL, DP Freeze Dry and Active Biologic Operations in Kalamazoo, Michigan

ROLE SUMMARY

  • This position is a leader of leaders, responsible for a sizable multi-shift team whose primary focus is Freeze Dry and Active Biologic Ingredients. The leader will be responsible for conducting the operations in a cGMP compliant environment.

  • The leader will ensure that manufacturing methods/environment will meet contemporary industrial, Regulatory, and Pfizer standards. He or she will work with the team leaders to ensure that teams are properly staffed to meet production requirements, to create and monitor budgets, to monitor and control production variances and ensure a safe working environment. The position will be responsible to interact with the assigned quality assurance, quality control, validation, engineering, technology services, supply chain, and regulatory department representatives in order to ensure that regulatory standards, company policies and site processes are met.

  • This individual will cultivate and reinforce appropriate Pfizer values, norms, and behaviors and will provide oversight to individuals and teams on personal development, performance, and quality related issues. This position will provide oversight of this team and will write and deliver performance reviews and perform second level reviews as required.

ROLE RESPONSIBILITIES

Manage the Freeze Dry and Active Biologic Ingredients operations across three aseptic cores , twenty five freeze dryers, and an active biologic production facility on a 7x24 basis. Ensure that the operations are cGMP compliant. Ensure that the teams are staffed to meet production requirements. Creates, monitors, and is responsible for achieving department's budget. Monitors, reports, and reacts accordingly to production variance reports. Ensures a safe operation is in place. Ensures that all manufacturing methods and practices are consistent with industry and Pfizer standards. Interacts with department's assigned representatives of quality assurance, quality control, validation, engineering, maintenance, technology services, supply chain, business technology, and regulatory to ensure the operation's manufacturing needs, regulatory standards, and company policies are met. Ensures that colleague training programs are suitable and effective to support cGMP requirements. Guides operation through appropriate application of technical knowledge to troubleshoot process upsets, provide investigative support, analyze process data, and identify immediate/short term corrective actions to support daily operations. Oversees the shop floor scheduling activities and ensures productive use of capacity. Interacts frequently with regulatory auditors as a strategist to represent operations and as the lead tour strategist for areas of responsibility. Timely escalation of personnel, environmental, safety, quality, and operational issues. Work across multiple departments in Drug Product Operations and manage multiple competing priorities and requirements, including performing Drug Product and functional responsibilities. Note that these activities may not be time bound to core hours or presence at the site.

BASIC QUALIFICATIONS

  • Bachelor's degree in Chemistry, Biochemistry, Microbiology, Engineering, Pharmacy, or related science

  • Minimum of 9 years of directly related experience

  • Strong analytical, presentation and relationship management skills

  • Proven track record of delivering results consistently while being a role model for the Pfizer Leader Behaviors

  • Knowledge of cGMPs (US & EU), OSHA, ISO and other regulatory agency standards and requirements applicable to a pharmaceutical production facility.

PREFERRED QUALIFICATIONS

  • Previous experience as a manager of colleagues is required (minimum of 5 years) and experience leading front line team leaders

  • Excellent verbal, written, and presentation skills

  • Demonstrated innovation and continuous improvement of work processes and deliverables

  • Freeze dry and/or active biologic ingredients experience

  • Lean and/or six sigma expertise

PHYSICAL/MENTAL REQUIREMENTS

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

  • Aseptic Gowning (to at least Grade C)

  • This position will operate Primarily on First Shift, but will have direct reports on all three shifts. Occasional off-shift and weekend work will be required.

  • Position may hold ad hoc memberships on several corporate teams, travel to other Pfizer sites may be required infrequently.

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: December 21, 2018

  • Eligible for Relocation Package

  • Eligible for Employee Referral Bonus

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