Senior Manager, Manufacturing, Cell Therapy Manufacturing
Company: Bristol Myers Squibb
Location: Ayer
Posted on: January 18, 2023
Job Description:
At Bristol Myers Squibb, we are inspired by a single vision -
transforming patients' lives through science. In oncology,
hematology, immunology and cardiovascular disease - and one of the
most diverse and promising pipelines in the industry - each of our
passionate colleagues contribute to innovations that drive
meaningful change. We bring a human touch to every treatment we
pioneer. Join us and make a difference. PURPOSE AND SCOPE OF
POSITION:BMS is seeking a manager of Cell Therapy Manufacturing for
a new manufacturing facility in Devens, MA. The Senior Manager will
support the scale-up and commercial licensure of the Cell Therapy
facility. In addition, the Senior Manager will be responsible for
the people manufacturing both clinical and commercial product. This
person will be a key leader responsible for GMP. This position will
supervise shifts that cover 24/7 cell therapy operations and
supervise manufacturing associates and supervisors. REQUIRED
COMPETENCIES: Education and Experience:
- Bachelor's degree in relevant science or engineering
discipline, or equivalent in work experience. Advanced degree
preferred.
- 12+ years of relevant work experience within pharmaceutical or
a similarly regulated industry
- 8+ years of direct experience in cGMP biologics manufacturing,
experience in cell therapy manufacturing preferred
- 6+ years supervising staff in a management role
- Knowledge of Lean Manufacturing principles required.
- Cleanroom garments and personal protective equipment will be
required in designated areas which cover head, parts of the face,
core body, and legs/feet.
- Ability to work in the vicinity of strong magnets.Knowledge,
Skills, and Abilities:
- Advanced understanding of cell culture, cryopreservation,
purification, and aseptic processing or lab techniques
- Advanced knowledge of relevant regulations and guidance;
available to act as a resource for colleagues
- Independent decision-making capability and ability to think
conceptually and understand impact of decisions
- Technical writing capability and experience with writing,
approving and training staff on SOPs, Batch Records, Change
Controls, deviations and CAPAs.
- Proficient in MS Office applications
- Proven leadership ability to carry out difficult decisions in a
logical, rational manner, and demonstrated ability to work as a
senior management team member and to engage and influence team
members in a matrixed environmentDUTIES AND
RESPONSIBILITIES:Establishes and manages multiple manufacturing
teams, shifts and manufacturing areas. This includes:
- Hiring, mentoring and developing exceptional people: Conducting
performance reviews and identifying opportunities for career growth
for supervisors and associates.
- Championing a culture of exceptional teamwork and communication
across the organization.
- Ensuring people have and maintain the appropriate level of
training necessary for CAR-T GMP manufacturing in a multi-product
commercial facility.
- Building effective cross-functional relationships with Quality,
Supply Chain, MS&T, EHS and F&E.
- Ensuring a culture that embraces safety in the work environment
and the safety of the patients by compliance with company
procedures and policies, and cGMP requirements. Models these
behaviors every day.Plans for and executes Engineering Runs, Tech
Transfer Runs and clinical operations for a new CAR-T product in
the Devens CTF Manufacturing Plant. This includes:
- Establishing department goals, tracking and reporting KPIs, and
driving a culture continuous improvement through innovation and
implementing lean manufacturing initiatives.
- Implementing and operating manufacturing systems that are
technically sound, promote effective and efficient operations, and
comply with cGMP requirements.
- Building and maintaining a training program for cGMP and
manufacturing systems.
- Ensuring schedules of the people, facility, equipment,
materials, and documents are established and maintained to support
the expected capacity of the facility for multiple CAR-T
products.
- Identifying and mitigating risks in manufacturing operations
that could negatively impact delivery of safe and effective
therapies to patients.
- Ensuring on time closure of deviations, CAPAs, and change
controls.
- Championing inspection readiness efforts and initiatives for
Right First-Time manufacturing.
- Establishing team policies, organizational structure, shift
structure, and career ladders for Associates, Team Leaders,
Supervisors and Managers.
- Reviewing and approving documents, including standard operating
procedures, batch records, material specifications, training
materials and validation protocols / reports.BMSCART VETERAN Around
the world, we are passionate about making an impact on the lives of
patients with serious diseases. Empowered to apply our individual
talents and diverse perspectives in an inclusive culture, our
shared values of passion, innovation, urgency, accountability,
inclusion and integrity bring out the highest potential of each of
our colleagues.Bristol Myers Squibb recognizes the importance of
balance and flexibility in our work environment. We offer a wide
variety of competitive benefits, services and programs that provide
our employees with the resources to pursue their goals, both at
work and in their personal lives. Physical presence at the BMS
worksite or physical presence in the field is an essential job
function of this role which the Company deems critical to
collaboration, innovation, productivity, employee well-being and
engagement, and enhances the Company culture.To protect the safety
of our workforce, customers, patients and communities, the policy
of the Company requires all employees and workers in the U.S. and
Puerto Rico to be fully vaccinated against COVID-19, unless they
have received an exception based on an approved request for a
medical or religious reasonable accommodation. Therefore, all BMS
applicants seeking a role located in the U.S. and Puerto Rico must
confirm that they have already received or are willing to receive
the full COVID-19 vaccination by their start date as a
qualification of the role and condition of employment. This
requirement is subject to state and local law restrictions and may
not be applicable to employees working in certain jurisdictions
such as Montana. This requirement is also subject to discussions
with collective bargaining representatives in the U.S.Our company
is committed to ensuring that people with disabilities can excel
through a transparent recruitment process, reasonable workplace
adjustments and ongoing support in their roles. Applicants can
request an approval of accommodation prior to accepting a job
offer. If you require reasonable accommodation in completing this
application or if you are applying to a role based in the U.S. or
Puerto Rico and you believe that you are unable to receive a
COVID-19 vaccine due to a medical condition or sincerely held
religious belief, during or any part of the recruitment process,
please direct your inquiries to . Visit to access our complete
Equal Employment Opportunity statement. BMS will consider for
employment qualified applicants with arrest and conviction records,
pursuant to applicable laws in your area. Any data processed in
connection with role applications will be treated in accordance
with applicable data privacy policies and regulations.
Keywords: Bristol Myers Squibb, Nashua , Senior Manager, Manufacturing, Cell Therapy Manufacturing, Executive , Ayer, New Hampshire
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