Job Description
GENERAL SUMMARY
The Associate Director - Fermentation Technology Lead within our Bulk Facility Technical Operations organization will be responsible for tactical and strategic decisions related to facility start-up and stabilization. The Associate Director will ensure optimized product quality and manufacturing processes, regulatory compliance, employee and environmental safety, integration of new/existing technologies, customer service, resource utilization, financial performance and fiscal stewardship.
The role encompasses fermentation area support for technical/process issues, strategic projects, deviation management, change management, quality risk management, licensure and filing project management, and human resource activities for a technical staff.
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GENERAL PROFILE
- Provides leadership and direction for a team of individual contributor full-time employees
- Adheres to site/project priorities based on departmental budget and profit plan to address resource and operational challenges
- Is part of the GBF Technical Operations Leadership Team along with partners from other suite teams
- Also interacts with other functional groups, including Operations, Quality, Automation, Maintenance and Safety
PEOPLE MANAGEMENT
- Coaches/mentors direct reports responsible for their area within Technical Operations
- Executes tasks related to people development such as one-on-ones, mid-year reviews, year-end review/calibration, team staff meetings, new employee onboarding, etc.
FINANCIAL MANAGEMENT
- Assists Technical Lead with managing the Technical cost center, including capital spend, creating and managing all profit plans and forecasts throughout the year related to hiring and schedule adherence
TECHNICAL SUPPORT
- Responsible for execution of deviation management activities, including coaching staff through incident/investigation authoring, QN review/approval, speaking to QNs pulled for audits/inspections
- Responsible for oversight and project management of regulatory filing preparedness in the Fermentation area - including interactions with CMC-Reg, providing GBF source documents, escalating needs and issues related to license readiness
- Responsible for technology transfer and qualification of the fermentation process, including successful completion of engineering runs, PPQ stage gate review, successful PPQ execution, and maintaining alignment with the sending/partner sites in the network
- Collaborates with internal/external partners, e.g. Other of our Company ck sites, CMC-Reg, Procurement, Planning, Quality CoE, etc
- Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments
- Leads aspects of regulatory inspections by presenting and defending technical documentation, investigations, and change controls
- Evaluates and develops innovative process technologies, continuous process improvements and post launch process enhancements
- Provides post approval support and subject matter expertise support to ongoing manufacturing activities.
- Develops a team of competent technical professionals through one-on-ones, midyear reviews, year-end reviews and continuous improvement efforts
Essential:
- Bachelor Degree in Engineering, Science or related field
- Minimum 7 years of experience in a GMP Facility or Capital Project as a technical staff member (5 Years with a Masters Degree, 3 years with a PhD)
- Previous people management experience required, including contractor management
- Strong planning, scheduling, and time management skills
- Working knowledge of regulatory requirements in accordance with GMP manufacturing operations
- Good oral and written communication skills
- Experience with tech transfer activities and regulatory inspections
- Experience with deviation management and change control
- Project management, including change control, validation and equipment qualification
WORKING RELATIONSHIPS
- Reports to Director, GBF Technical Operations
- Manages and interacts with employees within own department
- Frequent interaction with employees from other departments
- Interacts with representatives from regulatory agencies
- Interacts with external suppliers
Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE
Current Contingent Workers apply HERE
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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. 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 diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
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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, generally Tuesday, Wednesday and either Monday or 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".
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:
Domestic
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
10/11/2024
*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.
Job Posting End Date:10/11/2024
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:R315875