Job Description
We aspire to be the premier research-intensive biopharmaceutical company. At the forefront of research, we deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our team and be part of a company that uses the power of leading-edge science to save and improve lives around the world.
The Associate Director, Engineering within Biologics External Manufacturing Technology is accountable for achieving excellence in Compliance, Supply, Continuous Improvement & Cost Reduction in partnership with our internal technical partners and External Partner (EP) leadership, supporting the Vaccines and Biologics businesses. This individual works in collaboration with the Focus Factory Operations lead, modality specific Technology Leads, Large Molecule External Quality Assurance, and Procurement. The Associate Director must have biologics manufacturing experience, with broad process sciences and analytics, strong leadership skills, business acumen, and interpersonal skills.
Responsibilities
- Provide a single point of technical contact to assigned External Partners, impacted Company Manufacturing Division sites, and Commercialization.
- Provide technical oversight, management, and planning support for complex partnership models.
- Accountable to External Manufacturing for overall tech transfer delivery (on-time, within budget), working closely with the Operations Unit leadership to assure resourcing for each activity.
- Provide technical guidance to the External Partner, assess viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
- Collaborate with Procurement, External Manufacturing Operations, External Quality, Regulatory, and others to evaluate External Partner(s) for inclusion in the Company Network. Execute technical due diligence assessments at External Partner(s).
- Ensure tech transfers are positioned for successful business outcomes. Execute technical transfers and receiving site readiness activities.
- Lead team for identification and assessment of partner risks and develop mitigation plans.
- Develop and execute validation strategies for new and existing products.
- Provide manufacturing process support to External Partner(s) to resolve production issues and provide guidance on process and capacity optimization.
- Ensure targeted communications and alignment across technical functions. Guide and coach others in change leadership.
- Support/Coordinate/Manage complex investigations, with appropriate interface with other impacted manufacturing sites.
- Determine resource plans across all relevant technical functions.
- Provide a technical review of External Partner process change requests, deviations, and Master Batch Record changes. Minimize duplication of efforts between External Partner and Company systems.
- Drive and support Continuous process verification and process performance monitoring program for all products under responsibility.
- In concert with Commercialization, Quality, and Regulatory, ensure that External Partner(s) are inspection ready for all new product introductions and transfers.
- Understand the true regulatory requirements and partner with Operations, Quality, and the External Partner to develop more efficient ways to meet these requirements.
- Collaborate with External Partners to achieve business goals and establish a common culture that benefits both our company and EP.
Qualifications
Required
- A Bachelor’s degree in Engineering, Science, or Business.
- Minimum of 8 (eight) years post-bachelor’s degree experience in Drug Substance and/or Drug Product vaccines and/or biologics manufacturing, engineering, and/or technical support of operations.
- Expertise and demonstrated accomplishments leading technical transfers.
- Advanced problem-solving skills and experience leading teams to resolve complex business or technical issues.
- Excellent leadership, collaboration, change management, interpersonal, analytical skills, and engagement as a team player with dependable interpersonal and communication skills (both verbal and written).
Preferred
- An advanced degree in Engineering, Science, or Business.
- Experience in leading cross-functional teams in support of manufacturing operations at internal sites or External Partner(s).
- Expertise and demonstrated accomplishments with Lean Manufacturing applications to ensure year on year productivity improvements.
- Ability to motivate a team around a common vision and deliver expected results.
- Creative, innovative, self-motivated, apply problem-solving skills, and solid base in engineering fundamentals and process troubleshooting.
- Experience in complex international environment with matrix organization structures.
- Experience in Large Molecule unit operation design, startup, and/or operation.
Travel Requirements
- 30% for partner assignments outside of primary location (primarily traveling within designated US region). Travel and flexibility in partner assignment location is required; may require short term travel assignments.
Required Skills:
Ability to Coordinate, Ability to Coordinate, Adaptability, Automation Systems, Biologics, Capital Project Management, Change Management, Clinical Manufacturing, Competency Development, Contract Manufacturing, Data Analysis, Decision Making, Drug Product Manufacturing, External Manufacturing, Interpersonal Relationships, Lateral Thinking, Lean Manufacturing, Manufacturing Scale-Up, Matrix Management, Partner Relationship Management (PRM), Problem Identification, Process Alignment, Productivity Improvements, Regulatory Compliance, Regulatory Management {+ 11 more}
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.
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 an 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
The salary range for this role is $142,400.00 - $224,100.00
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.
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
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
25%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
09/4/2026*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.
Associate Director (Engineering), Biologics External Manufacturing Technical Operations employer: MSD
MSD is an exceptional employer that champions inclusivity and diversity, making it a great place for individuals looking to thrive in a supportive environment. With a strong focus on employee growth and development, particularly in the dynamic field of animal health, team members benefit from collaborative partnerships and innovative sales strategies tailored to the unique needs of farmers in Wales. The company fosters a culture of high performance while ensuring that employees feel valued and empowered to make a meaningful impact in their roles.
StudySmarter Expert Advice🤫
We think this is how you could land Associate Director (Engineering), Biologics External Manufacturing Technical Operations
✨Join Local Manufacturing Groups
Getting involved in local manufacturing groups or associations can seriously boost your visibility. These groups often have insider info on job openings and networking events, plus they help you connect with like-minded folks in the industry. Check out what's happening in your area!
✨Show Off Your Skills in Practical Spaces
Consider participating in workshops or open days at manufacturing companies. It's a great way to show off your hands-on skills in a real-world environment and can sometimes lead to job offers right on the spot. Keep an eye on announcements from local manufacturers for these opportunities!
✨Leverage the Power of Internships
While you're looking for full-time positions, don't underestimate the power of internships! Even if you don't see a direct role, securing an internship at a company can open doors to future jobs. Many manufacturing firms prefer to hire from their intern pool, so it's definitely worth considering.
✨Apply Directly Through Company Websites
When you find a role at a company you love, like MSD, apply directly on their website. This way, you’re more likely to be noticed by the hiring team. Plus, showing that you took the time to seek out their application process highlights your genuine interest in the firm!
Some tips for your application 🫡
Showcase Your Technical Skills:In the manufacturing-production sector, it's crucial to highlight your technical skills and experience. Make sure your CV features any relevant qualifications, such as certifications in machinery operation or production management, and don’t forget about any specific systems or software you’re familiar with. This can really set you apart!
Emphasise Teamwork and Communication:Working in manufacturing often means being part of a larger team. Highlight your experience in collaborative projects or environments where communication was key. Maybe you have experience with lean manufacturing principles? Talk about how you worked with your team to improve productivity and maintain quality.
Tailor Your Cover Letter to the Company:Don’t just recycle an old cover letter! Take the time to tailor your cover letter to MSD specifically. Mention what excites you about their production processes or products, and how your previous experiences can contribute to their goals. We want to see your enthusiasm for the role!
Use Concrete Examples of Your Achievements:When detailing your work experience, include measurable achievements that can demonstrate your impact. Whether it’s improving efficiency by a certain percentage or successfully leading a project, these specifics can make a huge difference. Numbers speak volumes in the manufacturing world!
How to prepare for a job interview at MSD
✨Know Your Manufacturing Processes
Before you walk into the interview with MSD, brush up on the specific manufacturing processes relevant to the role. Understanding lean manufacturing principles or quality control techniques could give you a solid edge to discuss how you’d fit into their operations.
✨Technical Questions Are Key
Be prepared for technical questions around machinery, production scheduling, or materials handling. Make sure you can confidently explain how you've dealt with these in past experiences or internships. Knowing industry-specific software could also be a big plus!
✨Showcase Your Problem-Solving Skills
Manufacturing environments often focus on continuous improvement. Be ready to discuss specific instances where you’ve solved a production issue or implemented a process improvement. It’s all about demonstrating your analytical thinking and hands-on approach.
✨Align Your Values with Quality and Safety
In a full-time role, companies like MSD value commitment to quality and safety. Be prepared to discuss how you prioritise these factors in your work. It’s about showing that you’re not just looking for a job, but that you genuinely care about contributing positively to their production environment.
