Job Description

Join our Manufacturing Operations team as a Sr. Operations Specialist (Fermentation) in Desoto, Kansas! The Sr. Specialist will serve as both Project Lead and system/sub-system owner for key functions supporting manufacturing operations in critical GMP, compliance, and operational improvement activities. You will serve as a pivotal Change Manager and Stakeholder for change management activities at the De Soto site and support team development and mentorship.

This role is ideal for candidates with a "Safety First, Quality Always" mindset, passionate about creating a culture of continuous improvement and leading by example. You will own the execution of effective problem solving within Operations and ensure that outcomes are shared appropriately with cross-functional teams.

Primary Responsibilities Includes:

Process Leadership:

• Design, monitor, and optimize fermentation processes for maximum yield and product quality.
• Scale up fermentation from laboratory to pilot and full production levels.
• Analyze microbial growth conditions and maintain sterile environments.
• Troubleshoot and resolve technical issues during fermentation, including equipment and process deviations.

Safety Compliance:

• Demonstrates a strong compliance mindset (EHS, Quality, and Finance) and continuously sets a high standard for themselves and their team.
• Responsible for safety event management and root cause investigation.

Quality Compliance:

• Accountable for the on-time completion of Quality compliance tasks in relation to Deviation, CAPA, Change Control Management, and Project Management.
• Accountable for all aspects of Quality Assurance including cGMP, RFT, and good documentation practices and provides coaching to the Operations teams.
• Accountable for the update, review, and approval of GMP documentation required in relation to assigned projects, including, but not limited to:
  • Standard Operating Procedure
  • Manufacturing Directions
  • Qualification Protocols
  • New product/product transfer documentation

Productivity:

• SAP Key User and Subject Matter Expert (SME).
• Accountable for the execution of effective problem solving within Operations and ensures that outcomes are shared appropriately.
• Recognizes and investigates opportunities for financial savings.

Employee Development

• Acts as a Subject Matter Expert (SME) to support coaching and skills development within the Operations.
• Acts as a Subject Matter Expert (SME) for the delivery of training material specific to their assigned responsibilities.

Required Experience and Skills:

• Bachelors in a relevant scientific discipline.

• Minimum of 5 years of experience in Fermentation and/ or Aseptic Processing in Manufacturing Operations.
• Experience working in a GMP manufacturing environment.
• Experience with one or more of the following technologies/processes: Bacterial fermentation, Tangential Flow Filtration or Chromatography,
• Experience with safety event management and root cause investigation
• Understanding of aseptic processes used in manufacturing.
• Experience using quality improvement tools and continuous improvement processes and site quality metrics.

Required Skills:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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:

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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".

The salary range for this role is

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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R374836