Position Description
The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical manufacturing plant in Rahway, New Jersey. The Sterile Production Supervisor manages a team of technicians for daily operations that support sterile supply, aseptic formulation, aseptic filling, and visual inspection.
This role require adherence to GMP procedures, strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects. Positions may also support commissioning, qualification, and demonstration of new equipment and technologies. Successful candidates will collaborate closely with team members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and clinical pipeline.
Accountability
First line operations supervisor with a team of individual contributor production direct reports
Ensure that shift objectives are achieved while reliably supplying quality product at a competitive cost consistent with all applicable internal and external regulations for quality (GMP), safety, etc.
Attention to Detail: Maintain meticulous records of formulation processes, including ingredient quantities, equipment used, and environmental conditions.
Tactical and strategic shift management, including collaboration with indirect staff
Batch Adaptability: Quickly adapt to changes in batch procedures and production schedules, demonstrating flexibility and problem-solving skills.
Promote the behaviors and principles that drive continuous improvement
Duties
Coordinates and supervises the daily activities of individual contributors. Sets priorities for the team to ensure task completion; coordinates work activities with other supervisors and develops plans to meet short-term objectives.
Identifies and resolves standard day to day quality, technical, and operational problems within own unit. Makes decisions – guided by policies and standard operating procedures – that impact the efficiency and effectiveness of own unit. Receives guidance and oversight from the Operations Director.
Works within budgetary/financial objectives set by Director
Compliance – Responsible for creating and sustaining a culture that ensures that compliance (Safety, Environment, cGMP, etc.) are imperatives for the business. Responsible for establishing a Right First-Time culture by reducing waste and constantly driving continuous improvement. Responsible to review and approve compliance documents, as per procedures or need.
Supply – Exercise judgement and decision making to ensure quality product is reliably produced while managing cost. Responsible for Shift(s) supply performance metrics (Schedule Adherence, Release on Time, Customer service performance, Product Lead Time, etc.).
Continuous Improvement – Accountable for developing a our Company Production System (MPS) and continuous improvement culture while achieving MPS Targets and business results for the Shift(s). Develop strategic initiatives related to the manufacturing process, equipment and human resources in support of long range operating plans. Report Shift(s) monthly metrics and any action plans to address gaps to Management. Identify, prioritize and champion improvement initiatives to improve process efficiency, cycle time, and yield, reduce process variability and eliminate waste.
People Management – Responsible for creating and sustaining a highly engaged workforce through utilization of our Company Leadership Behaviors and Inclusion. Provide coaching on professional development and career paths. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation. Provide feedback and input on performance evaluations for indirect staff. Support Talent Management.
Position may require work outside of routine hours (e.g. nights / weekends), depending on business needs.
Core Skillsets
Aseptic experience: Experience in working in Grade A environment is required, including aseptic qualification and performing environmental monitoring.
Ability to be flexible and understand risk.
Collaboration: Able to communicate clearly with team and work closely with other teams to ensure on time delivery of supplies.
Leadership style – adaptive; high performance coaching; servant leader
Compliance mindset to safety, environmental, and quality regulations
Education Minimum Requirement: Bachelor’s degree in business administration, Science, Engineering or another technical field with a minimum of 4 years of experience, or at least 7 years' experience in pharmaceutical manufacturing or processing with HS diploma.
Minimum (4) years’ experience in a functional area, such as operations Management, Quality, Technical Operations, Technology, Engineering or Maintenance.
Minimum (2) years’ experience in aseptic/sterile drug product manufacturing or processing
Minimum (2) years’ direct supervisory experience.
Demonstrated experience of interacting with site, divisional or regulatory audits
Current Employees apply HERE
Current Contingent Workers apply HERE
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
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, Monday - 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”.
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Relocation:
Domestic*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.
Originally posted on Himalayas
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