Senior Product Technical Lead

4 weeks ago

Andover, United States Pfizer Full time
Why Patients Need You

Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need when they need them.

What You Will Achieve

The Site Technical Services Group (STS) is seeking a highly motivated individual as a Senior Product Technical Lead. The ideal candidate will have hands on, and strong leadership experience with large scale biopharmaceutical processes/equipment principles and practices. A strong regulatory compliance and Good Manufacturing Practice mindset/experience is required and who can work independently.

As a Senior Product Technical Lead, your comprehensive knowledge of the principles and concepts in the Product Lifecycle Management and good understanding knowledge of other areas will enable you to lead your products at the site level. Your ability to develop and manage products will facilitate in achieving objectives, apply knowledge to internal/external business challenges to provide input into recommendations for improvements. While managing product lifecycle, you will be able to anticipate and troubleshoot roadblocks and influence teams to achieve project goals.

It is your dedication that will make it possible for customers and patients to receive the medicines they need, when they need them.

How You Will Achieve It

Ownership of site-level product technical and lifecycle strategies compatible with and supportive of site strategy and network product strategy; building teams supporting product technical management and lifecycle projects at site level.Lead site in maintaining and improving control strategies for Drug Substance (DS) and DS Intermediates manufacturing for licensed products in collaboration with network technology teams.Ownership of programs and risk management for maintaining manufacturing process for licensed products in the validated state.Technical Leadership for product lifecycle projects for the purpose of maintaining and improving process performance, process robustness, regulatory compliance, supply assurance, loss reduction, and cost-of-goods.Technical Leadership on process troubleshooting, investigation, and improvement.Lead internal and board of health inspections technical discussions for biopharmaceutical products.Leads and drives alignment with stakeholders on technical strategies and priorities.Lead regulatory assessments, queries, and implementation of process improvements, process changes and new manufacturing technologies under critical timelines.

Qualifications

Must-Have

Applicant must have a High School Diploma (or Equivalent) with 10+ years of relevant experience;OR an Associate's degree with eight years of experience;OR a Bachelor's degree with at least 5+ years of experience;OR a Master's degree with more than three years of experience;OR a Ph.D. with 0+ years of experience.Demonstrated leadership, management and technical capabilitiesEffective written and verbal communication skills.Strong interpersonal skills and experience working in a team environment across business functions and matrix organizations.Independent, self-motivated, and flexible with the ability to work effectively in a dynamic, problem-solving environment.Strong mammalian or microbial process expertise.Proven project management, analytical, problem solving skillsUnderstanding of biological / vaccine requirement.

Nice-to-Have

Relevant pharmaceutical experiencePractical experience in facilitating and conducting risk assessmentsExperience in problem-solving, negotiations, presentation and working in a matrix based multi-layered organization, including comprehensive understanding of DAMIC (six sigma) tools and practices and a focus on continuous improvement.Strong technical understanding of pharmaceutical processes and the impact of technical change.Demonstrated experience and competence in organizing, planning and problem solving related to biopharmaceuticals drug substances compounds.Demonstrated experience on regulatory submission strategy, audit responses and technical discussion with board of health.

PHYSICAL/MENTAL REQUIREMENTS

• Perform complex data analysis for process analysis, troubleshooting or process improvement. Thought leader regarding process robustness/process capability.
• Able-bodied; must be able to climb flights of stairs and be standing for ~1-2 hours at a time.
• Inspiring - Motivate and develop self and others to drive the business forward.
• Courage - Consistently demonstrate accountability and integrity.
• Resilience - Respond to change with agility, optimism, and innovation.
• Decisive - Manage complexity to make timely informed decisions.
• Focus - Develop impactful short- and long-term solutions for our customers and patients.
• Connected - collaborate with others to accomplish shared goals

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Work Schedule: work schedule is primarily M-F on days but is in support of a 24/7 manufacturing environment. As such, work hours may need to adjust (including nights and weekends) from time to time.

Work Location Assignment:Flexible

Relocation Assistance: NO

Last date to apply: 9/2/24

The annual base salary for this position ranges from $109,400.00 to $182,300.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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

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. This position requires permanent work authorization in the United States.

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