Sanford, NC, United States
As a member of the Gene Therapy Manufacturing Technical Services team (MTS) located in Sanford NC, the Senior Manager will lead the staff and laboratory activities of the Gene Therapy MTS Pilot Plant.
During the initial phase the incumbent in this role will work closely with the engineering team on the design of the Pilot Plan facility and equipment will be responsible for establishing the GTx MTS Pilot Plant team. Team will be primarily laboratory-based and will focus on:
Lab support for technology transfer of processes from development into GTx Manufacturing Operations
-Laboratory-based investigational support to Manufacturing Operations
-Evaluation of process changes/improvements and impact of materials changes on process and product CQAs
Senior Manager in this role will be responsible for budget and staffing levels, performance evaluation, salary recommendations and career development of all individuals within the new GTx MTS Pilot Plant organization (GTx-MTS-PP) after it is established.
Defines user requirements for the pilot plant laboratories and equipment and supports engineering team in the design and setting up the pilot plant.
Responsible for the personnel, laboratories and all scientific / technical activities of GTx MTS Pilot Plant
Provides technical management and leadership to the team of cell culture, purification, analytical scientists and process engineers (BS, MS, PhD educational levels).
Represent the interests and activity of the group in the external community academia/scientific meetings - where appropriate. Stay current with the sciences of interest to Pfizer s activities and products. Where appropriate, sets up and collaborates on projects of interest to Pfizer with academic groups or other external consortia.
Maintains the depth and scientific capability of the GTx MTS Pilot Plant team. Promotes and drives technical and personal development of the team members.
Assures the number and skillsets of the resources are sufficient to serve the needs of the immediate customers of the group. Take action to implement a model of resourcing that assures sustainability and consistency of the group's activity and output.
Ensures the Pilot Plant group work safely at all times. Stays current with, and applies, all good work safety practices and Pfizer requirements.
Works closely and effectively with the MTS team lead and the Sanford GTx leadership team to assure that site and GTx products support needs are being delivered from the GTx Pilot Plant
Proactively connects to, and maintains effective communications with the site GTx leadership team to assure technical support in a timely manner. Act visibly as subject matter expert and technical point of contact when issues arise and laboratory support is needed
Establish and leverage connectivity with the broader MSAT drug substance and Pilot Plant network (i.e. MSAT Drug Substance, Andover & Sanford groups, Puurs EPP, etc.) as part of the broader network of similar groups in GTE LM Drug Substance and Drug Product technical groups.
Establishes contacts across the network to foster development, innovation and replication of best practices.
PhD or MS in a scientific/technical discipline of the life sciences such as biochemistry, biology, biochemical engineering or similar
12 years of experience in scientific / technical roles within the biotech industry, supporting the development and commercialization of biotech products, experience with gene therapy products is a plus
Advanced technical expertise in a number of the following: mammalian cell culture science, virology, downstream technologies, analytical sciences
Experience in designing and executing components of major experimental programs for biologics drug substance production in the laboratory or pilot-plant setting
Experience in taking major process and method changes through to the regulatory filing stage for marketed biologics
Proficient user of problem-solving, risk analysis and statistical tools
Practitioner of the six sigma and CI suite of tools including DMAIC, VSM, SIPOC etc.
Hands-on familiarity with drug regulations/regulatory processes and quality/GMP/compliance systems of the pharmaceutical industry
Demonstrated record of success in leading teams and of direct supervision of scientific staff with varying levels of education and experience (BS, MS and PhD)
Excellent communication skills (verbal written).
Ability to matrix-work effortlessly across team and organizational / hierarchical boundaries.
Position requirements are typical for an office and lab based work environment. There are no unusual requirements for this position.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
The incumbent in this position would typically work a routine weekly work schedule but travel to other sites, conferences and other events would be normal and expected.
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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.
Last Date to Apply for Job: 21 January, 2019
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.
Website : http://www.pfizer.com
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