Director mRNA Analytical Stability Strategist Job at Pfizer
POSITION SUMMARY
This posting is for a Director, PGS mRNA Analytical Stability Strategist
As the mRNA Analytical Stability Strategist you will be accountable for leading the design, implementation and change management of all the platform stability programs. You will work to drive alignment across the network, conveying one perspective on stability related matters. Have oversight of the forecast and capacity constraints and drive an E2E process to ensure stability program commitments are met. You will maintain a view of chambering and testing capacity across the Network and seek to optimize testing locations based on synergies with both on-going and upcoming programs.
POSITION RESPONSIBILITIES
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Leads the implementation and oversight of project stability programs for mRNA products.
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Leads an E2E process to ensure there is clear visibility of testing capacity at the sites.
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Leads the mRNA Stability Forum to ensure consistency across the Network.
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Critically assesses and summarizes analytical results including but not limited to Compendial test methods, HPLC, electrophoresis, PCR, and various bio-assays in order to support product stability
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Authors stability filings and submissions, HA queries and commitments, and other key regulatory and GMP documents.
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Advise on market excustion queries.
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Communicates project plans, stability strategies, stability mitigation plans and project risks to management and key stakeholders.
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Maintain a view of network capacity and seek to optimize testing locations. Develop specific recommendations addressing long term strategy to support the platform and communicate these recommendations to PGS leadership
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Actively participates and reports progress into matrixed project teams to meet program expectations and project milestones.
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Contributes to the achievement of goals and influences at the work group/project team/cross-line level.
ORGANIZATIONAL RELATIONSHIPS
The role routinely interacts with the following roles: mRNA Analytical Lead, mRNA Quality Product Lead, mRNA Technical Lead site stability and analytical teams, Co Development leads.
RESOURCES MANAGED
Financial Accountability
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The role does not have any budget oversight.
Supervision
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The position will have no direct reports. The position will have matrix responsibility for ensuring the success of the sites and product platforms.
EDUCATION AND EXPERIENCE
Minimum Qualification Requirements:
Education:
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Minimum B.S. in any engineering, science or related discipline.
Experience:
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Proven leadership skills and ability to involve several levels of an organization to successfully meet the objectives.
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Minimum of 10 years' experience in the Pharmaceutical industry with significant experience in biologics, vaccines, and/or biopharmaceuticals. 5 years of robust site Quality management experience (preferred)
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Demonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices and systems, and personal management skills.
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Proven leadership skills and ability to work across functions with all levels of the organization where the incumbent may not have direct authority.
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Demonstrated skills in analyzing, organizing, and project management with a high sense of urgency.
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Demonstrated change agility to successfully manage a high degree of complexity and priorities.
TECHNICAL SKILLS REQUIREMENTS
- Strong knowledge of global cGMP quality and compliance requirements.
- Proven analytical skills capable of evaluating complex data to identify trends and signals.
- Excellent interpersonal and leadership skills including a demonstrated ability to positively influence and coach others, participate in teams at all levels of management and achieve results through others.
- Leadership and management of projects that require collaborative approaches, strong analytical skills, and a solid ability to understand business issues and processes.
- Experience authoring technical documents for regulatory or quality assurance purposes
- Proficiency in Microsoft Office or equivalent programs, familiarity with document management systems and databases is highly desirable.
- Experience in stability and or reference standards testing/activities is desired
- Demonstrated ability to align with internal functions to ensure a common organizational voice, to lead matrix project teams consisting of colleagues from different functional areas and/or departments.
- Must be fluent in English
PHYSICAL POSITION REQUIREMENTS .
- Based on the role travel is required (up to 5-10%).
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
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Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
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Work Location Assignment: Flexible
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Work Schedule: 8am – 5 pm
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Eligible for Shift Differential – NO
OTHER JOB DETAILS
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Last Date to Apply for Job: MARCH 09, 2023
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Additional Location Information: Belgium - Puurs; Belgium - Remote; Europe - Remote; Ireland - Dublin - Grange Castle; United States - Remote
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Eligible for Relocation Package – NO
Relocation assistance may be available based on business needs and/or eligibility.
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.
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