Sr. Spclst, Operations
Sr. Spclst, Operations
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Job Description
Job Description
Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a Safety First Quality Always mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials intermediates and finished products.
We have an exciting opportunity for a Senior Specialist to join the operations team for a capital project start-up in Durham North Carolina. The facility includes end-to-end processing of drug substance drug product including biotech culture growth harvest lyophilization product inspection and quality control laboratories. This position requires the ability to work independently with moderate to minimal supervision produce/complete various assignments requiring analytical ability demonstrate independent judgment creativity and problem-solving skills. This role also requires strong collaboration and communication skills to enable interfacing with both internal contacts (local site level) and external contacts (external customers above site partners vendors) to support these initiatives. The Senior Specialist must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation.
*This is a full-time position working Monday through Friday dayshift (normally 8:00am-4:30pm)
*Applicant must complete and be medically cleared for BCG medical clearance requirements:
questionnaire blood test chest x-ray
Position Description:
The duties of Senior Specialist Operations include but are not limited to:
Lead production schedule across operations (e.g. media drug substance drug product etc.). Interface with site planning and other IPT scheduling teams
Assist with facilitation of Project and site Tier meetings and help manage the operations project portfolio.
Guide cross-functional teams to advance project goals.
Manage area metrics/KPIs/schedule
Assist in developing operations controls and metrics to display the overall health of the project.
Develop and implement plans in partnership with other internal departments and above site and external contacts on different projects and initiatives.
Communication skills must be effective to interact with internal/external customers to manage projects assignments and workflow.
The successful candidate should be able to examine an issue from diverse perspectives (safety compliance automation equipment process and people) to best comprehend and resolve it at the root cause.
Key Competencies
Critical thinking problem solving and decision-making skills
Ability to see big picture and identify improvements aligned with business objectives.
Comprehension of program and project management fundamentals including indirect management skills.
Prioritization planning organizing and delegation skills.
Working with peers management and both internal and external partners.
Conflict management
Customer focused
Self-directed
Communication with diverse audiences
Strategic end to end thinking
Education Qualifications:
Bachelors degree in an Engineering or Science related field with at least five (5) years of experience in manufacturing/operations in a regulated industry OR
Masters degree in an Engineering or Science related field with at least four (4) years of experience in manufacturing/operations in a regulated industry
Required Experience:
Experience with Project Management and/or indirect leadership.
Preferred Qualifications:
Experience working in a pharmaceutical biotech or vaccines manufacturing environment
Scheduling experience
Lean Six Sigma Green Belt or Black Belt Certification
Experience with aseptic processing operations such as cell culture filling and/or lyophilization
Experience authoring technical documents such as Standard Operating Procedures (SOPs) and change requests within a current Good Manufacturing Practices (cGMP) context #EBRG #VETJOBS MSJR
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 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 anothers 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 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
$94300.00 - $148500.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 can apply for this role through (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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
Cleaning Supplies Cleaning chemicals raw materials biohazard wasteRequired Skills:
Adaptability Analytical Problem Solving Applied Engineering cGMP Compliance Communication Data Analysis Decision Making Inventory Management Lean Six Sigma Continuous Improvement Management Process Manufacturing Technologies Personal Initiative Process Improvements Process Optimization Production Planning Production Scheduling Training and Development Vaccine ManufacturingPreferred Skills:
Job Posting End Date:
07/3/2025*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.
Required Experience:
Senior IC
Employment Type
Full-Time
