Director Proteins Analytical Technology
Pfizer Inc.
Grange Castle, Ireland
Job posting number: #7151268 (Ref:pf-4886238)
Posted: May 31, 2023
Application Deadline: Open Until Filled
Job Description
JOB RESPONSIBILITIES:
- Provide technical leadership and partner with network leadership teams to set strategic plans to guide future technology initiatives and to meet technical support needs for all aspects of commercial product manufacture and lifecycle management.
- Responsible for talent development, providing direct line management and scientific leadership to multi-disciplinary team of scientists based at Grange Castle, (IRE).
- Provide strategic input to guide late-stage co-development programs and the associated regulatory strategies.
- Work closely with Pharm Sci and Leadership Teams to guide future test and characterisation technology strategy applications for future bios products.
- Lead technology transfer activities and development of submission packages for accelerated and Lightspeed programs as required.
- Drive continuous improvement initiatives to lead implementation of new technologies to improve operational robustness, efficiency, and performance.
- Partner closely with the Quality on key analytical network projects to support product compliance and lifecycle improvement initiatives.
- Provision of technical subject matter team expertise to network Quality, Regulatory and site Operation groups.
- Representation at various inter-company project meetings, project meetings with third party partners, global regulatory and scientific industry meetings.
QUALIFICATIONS & SKILLS
- B. Sc./M.Sc./Ph. D qualification in a technical/life sciences discipline.
- Minimum of 12+ years of experience in the biopharmaceutical industry supporting new product development, technology transfer, manufacturing and team leadership.
- Education and technical expertise in the majority of fields of: analytical chemistry, protein biochemistry, cell- and immunology-based bioassays and technology transfer.
- Proven record of delivering results in a fast-paced environment and effective communication to project teams and external partners (e.g. regulatory authorities).
- Proficient with the use of a variety of problem-solving, risk analysis and statistical tools.
- Highly proficient in Regulatory dossier strategy and CMC response development and with all aspects of the Quality/GMP/ICH/ compliance systems of the biopharmaceutical industry.
- Experience in progressing late-stage biologics through Process qualification and Regulatory submissions.
TRAVEL OR ENVIRONMENT REQUIREMENTS
- Domestic and International travel (less than 15%)
- Adaptation of schedule to work across different time zones as required
Work Location Assignment: Flexible
Additional Information
In order to be considered for this position in Ireland you need to be legally eligible to work in Ireland.
Please note there is no relocation support available for this position
How to apply
Make a difference today, all suitable candidates should apply with CV below. We are looking forward to hearing from you!
Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
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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