Senior Manager, Downstream Manufacturing

at  BristolMyers Squibb

Devens, MA 01434, USA -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate16 Jul, 2024Not Specified17 Apr, 2024N/ATrackwise,Support Groups,Maximo,Collaboration,Biochemistry,Yellow Belt,Communication Skills,Sap,Agile,Six Sigma,Technology Transfer,MasteryNoNo
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Description:

WORKING WITH US

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us.
Reporting to the Associate Director, Senior Manager of the Single Use Facility is responsible for advancing the biologics pipeline according to established work instructions and in accordance with current Good Manufacturing Practices (cGMPs). The role is based in a state-of-the-art facility utilizing single-use technology.
The Senior Manager leads and drives the execution of commercial and clinical manufacturing processes according to established electronic work instructions and production records for the manufacture of therapeutic proteins in accordance with Current Good Manufacturing Practices (cGMP’s). The Senior Manager is responsible for management of group whose primary focus is on execution of manufacturing processes, technical assessment of processes, maintaining a culture of compliance, innovation, and within their functional group. The Senior Manager is required to guide the personnel in their group with knowledge and technical knowledge to lead troubleshooting activities, provide investigation support, analyze process/equipment data, and identify and implement process improvements.

EDUCATION & EXPERIENCE REQUIREMENTS:

  • Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
  • Direct biologic manufacturing experience of 8+ years with minimum of 3+ years of previous supervisory experience which demonstrates proficiency in selection of team and effectively managing personnel issues is required.

REQUIRED SKILLS:

  • Mastery of SOPs and cGMPs within a regulatory environment.
  • Extensive knowledge of biopharmaceutical manufacturing process with a proven record in pharmaceutical technology, technology transfer, process development, manufacturing support.
  • Demonstrated aptitude for engineering principles and manufacturing automation systems.
  • Previous cross-functional supervisory experience which demonstrates proficiency in selection, motivating and retaining a superior team, effectively managing personnel issues and planning and administering financial resources.
  • Adaptable to a fast paced, complex and ever-changing business environment.
  • Effective communication and technical writing skills with support groups in the coordinating system to obtain needed cooperation and support as required in a timely and effectively manner.
  • Maintains a professional and productive relationship with area management and co-workers.

DESIRED SKILLS:

  • Experience in Lean, Yellow Belt, Agile, Tiers, Six Sigma or other operational excellence methodologies is preferred.
  • Proficiency with Syncade and DeltaV, and experience with process analytics trending tools, Trackwise, Infinity, Maximo, and SAP preferred.
  • Excellent oral communication skills.
  • Demonstrated leadership in professional settings.
  • Prior experience successfully participating on work teams where personal accountability, attention to detail, collaboration, and results were expected.

Responsibilities:

  • Drives site schedule by prioritizing resources/activities for manufacturing and support functions
  • Leads one or more operational groups, ensuing department goals and metrics are meeting or exceeding expectations. Identifies deficiencies, creates and executes action plans to mitigate issues.
  • Is responsible for the performance of all reporting team members.
  • Takes an active role in developing less experienced team members. This includes leveraging both internal and external relationships to build the best team possible.
  • Coordinates response to any developing issues and escalates as appropriate.
  • Ensures team adherence to Good Manufacturing Practices and safe work practices.
  • Ensures daily work coordination and distribution of work as demanded through the manufacturing schedule.
  • Manage to schedule and plan. Recognize impact for cross functional impact. Any variance to be captured and communicated to cross functional groups in real time.
  • Build partnership with Manufacturing Support to ensure seamless operations.
  • Provide communications upwards, downward and across as deemed fit
  • Manage decisions– acquire feedback, input, and consult as required.
  • Manages performance. Provide coaching, mentoring and development of staff. Conducts powerful conversations and provides meaningful and actionable feedback for staff growth and development. Executes all phases of the performance review process with diligence and on time.
  • Develops operational schedule in conjunction with scheduling and planning team. Drives increased scheduled adherence and cycle time.
  • Drives continuous improvements through staff engagement.
  • Demonstrated ability to lead manufacturing operations teams to achieve objectives.
  • Acts to promote a productive and cooperative climate. Helps to promote team effectiveness by engaging in a trusting, supportive partnership with others.
  • Encourages or facilitates a beneficial resolution of purpose. Resolve conflicts in a constructive manner that allows win/win solution.
  • Demonstrated ability to prioritize and coordinate activities within and across work groups; able to anticipate priority differences and issues and resolves these before problems occur, exceeds desired results.
  • Participates in the budget development process; effectively controls expenses (OT, Supplies, T&E) within their influence.
  • Develops stretch goals and uses effective motivation techniques to achieve them. Strong team diagnostic skill and strategy for team growth. Shapes site goals and policies. Able to effectively lead cross functional teams.
  • Provides shift continuity by attending the daily scheduling and triage meetings. Attends active maintenance, frozen schedule, and IEF meetings as a standing member.
  • Provides direct audit support.
  • Leads CAPA and eCC child actions to meet target due dates.
  • Drives accountability through Tier Meetings
  • Department approver of MBRs, BOMs, SOPs and other manufacturing documentation.
  • Works with Site Leadership to develop and implement strategic initiatives.
  • Acts as a consultant to project teams.
  • Provides on call support for the manufacturing team including active participation on the weekend and holidays.


REQUIREMENT SUMMARY

Min:N/AMax:5.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

BSc

Science engineering biochemistry or related discipline or its equivalent is highly desired

Proficient

1

Devens, MA 01434, USA