The Specialist in the Vaccine Biological Critical Reagents (BCR) group will be responsible for supporting the vaccines BCR programs. This position will perform hands-on laboratory work in biochemistry, virology, and/or cell biology techniques for biological critical reagents, such as reference standards, positive controls, and other critical materials. Under guidance from the Manager and/or Senior Specialist, the incumbent will help support the entire lifecycle of BC - Rs, from generation and te... more details
Job Description
The Specialist in the Vaccine Biological Critical Reagents (BCR) group will be responsible for supporting the vaccines BCR programs. This position will perform hands-on laboratory work in biochemistry, virology, and/or cell biology techniques for biological critical reagents, such as reference standards, positive controls, and other critical materials. Under guidance from the Manager and/or Senior Specialist, the incumbent will help support the entire lifecycle of BCRs, from generation and testing to inventory and shipping. All work will be conducted to the highest quality and conform to GMP and regulatory expectations.
Position Responsibilities:
The Specialist in the Vaccine BCR group will be responsible for helping support Critical Reagent programs in a fast-paced environment within the vaccines franchise.
The performance of the critical reagents used in release and stability testing within the Quality Control Laboratories is important for release of vaccines products.
This position requires experience in general cell biology, molecular biology, virology and/or biochemistry techniques.
Under the guidance of a Manager and/or Senior Specialist, the Specialist is responsible for helping to manage the complete lifecycle of critical reagents, including reference standards, positive controls, anti-sera and other critical materials.
The BCR lifecycle includes acquisition, certification and qualification testing, implementation, sample and inventory management, and ongoing monitoring and replacement of the material as required per established procedures.
Additionally, the individual will demonstrate understanding in the implementation, execution and management of BCRs, and ensure work is conducted to the highest quality, and conforms to current Good Manufacturing Practices and regulatory expectations.
The Specialist will help provide bioanalytical support to Global our Manufacturing Division sites as needed and respond to regulatory questions, co-author analytical license sections, and support regulatory inspections as necessary.
In addition, the Specialist will develop the skills necessary to influence others towards gaining alignment with peers, stakeholders, and customers; understands how one’s job responsibilities contribute to the departmental goals; manages assigned tasks within given timelines and demonstrates the ability to distribute accurate information but may need guidance in crafting messages for target audiences; and independently solve problems that arise within job responsibilities and expectations.
Education Minimum Requirement:
B.S., M.S. in Biology, Virology, Molecular Biology, Biochemistry, or related biological science
Required Experience and Skills:
Bachelor’s with a 3 to 5 years of laboratory experience.
Demonstrated leadership and teamwork skills
Ability to work independently
Ability to lead project teams
Ability to plan, prioritize, and effectively manage tasks independently
Ability to meet deadlines and product quality deliverables
Ability to work effectively in a collaborative team environment
Laboratory experience, knowledge of laboratory operations and bioanalytical instrumentation
Technical / analytical data comprehension
GMP experience
Preferred Experience and Skills:
Previous technical and/or analytical troubleshooting experience in biologics development, and/or quality laboratory experience
Proficiency in virology, biochemistry, and/or cell biology techniques
Statistical analysis experience and/or familiarity with JMP
Judgment, organization and project management abilities
Cell culture and antiserum testing experience
Knowledge of virology based testing assays (i.e. plaque assays, PCR, and TCID50)
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
VETJOBS
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
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Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Hybrid
Shift:
1st - Day
Valid Driving License:
Yes
Hazardous Material(s):
N/A
Job Posting End Date:
07/11/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
