Sr Specialist, Downstream Manufacturing Improvement and Support

Job Description

The Elkhorn Downstream Manufacturing Process Team is seeking a highly motivated Downstream Improvement and Support Sr. Specialist, within our Manufacturing Division. The Sr. Specialist will lead process improvements and change management initiatives within the blending, sterile filling and freeze-drying operations teams. The candidate must possess strong problem-solving and troubleshooting skills and be able to utilize data for decision making. The Sr. Specialist will provide leadership and guidance around product impact from technical or compliance deviations and collaborate with Quality, Biotechnology Solutions and Integrated Process Teams to ensure product quality and compliance. The selected candidate must embrace and be committed to establishing an empowered team culture, with the goal of each employee reaching their fullest potential and having accountability, authority and responsibility to one another, and the community. Enthusiasm for continuously learning and imparting that knowledge on others is a requirement.

Primary responsibilities include, but are not limited to the following:

• Models Company leadership principles and inclusive behaviors.
• Provides coaching and supports skills development and process capabilities within the team.
• Is responsible for providing effective feedback and coaching within the team during the Performance Management cycle and ensuring that Employee Development Plans (EDP's) are in place.
• Write event notifications to document atypical events in production and lead investigations as necessary, including product complaints.
• Create CAPAs and change controls to drive downstream improvement.
• Develop process improvement procedures to improve downstream efficiency.
• Collaborate with other departments, such as Quality, Environmental Health and Safety, Technical Support, Planning, and Maintenance to ensure alignment of goals.
• Update documents in GOP environment.
• Supports the on-time completion of Quality compliance tasks in relation to Deviation, CAPA and Change Control management.
• Supports all aspects of Quality Assurance including cGMP, RFT and good documentation practices and provides coaching to the rest of their team.
• Contributes to creating a culture of continuous improvement and leads by example.
• Sponsors effectives problem solving and ensures that resources are available.
• Ensures visibility and communication of key productivity metrics with the teams.
• Recognizes and investigates opportunities for financial savings.

Qualifications:

Education Minimum Requirement:

• Associate's degree in a relevant scientific field (biology/ chemistry, life sciences) with a minimum of 4 years of laboratory or related vaccine production experience -OR- Bachelor's degree with a minimum of 2 years laboratory or related vaccine production experience

Required Experience and Skills:

• Excellent teambuilding skills that focus on mentoring and coaching
• Working knowledge of current Good Manufacturing Practices (cGMP's) or equivalent regulations
• Ability to prioritize, focus on and obtain results
• Working knowledge of aseptic techniques
• Proficient in Microsoft Office
• Excellent communication (verbal and written) and organizational skills
• Excellent problem solving and decision-making skills

Preferred Experience and Skills:

• Ability to gown into and work within an aseptic environment.
• Experience in USDA or similarly regulated manufacturing environment.
• Expertise in the operation of batching and blending as well as high speed filling and capping.
• Experience in SAP and inventory control
• Lean and six sigma skills.
• Statistical math skills using Minitab.

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:

EEOC Know Your Rights

EEOC GINA Supplement

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
$94,300.00 - $148,500.00

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:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
No Travel Required

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Required Skills:
Adaptability, Aseptic Operations, Business Acumen, CAPA Management, Change Management, Collaboration, Deviation Reporting, Deviations, Problem Solving, Process Improvements, Taking Initiative, Team Collaboration, Team Mentorship, Vaccine Manufacturing, Working Independently, Writing

Preferred Skills:
Inventory Control, Minitab, Minitab Statistical Software, People Leadership, SAP Systems, USDA Regulations

Job Posting End Date:
07/5/2025
*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.

Requisition ID:R354103