Associate Director, Engineering- External Manufacturing Technology, Large Molecule ( MERCUSR113495ENUS)
The Associate Director will be the key technical leader interface between our company and External Partners for the Large Molecule (Biologics/Vaccines/Sterile) External Manufacturing (ExM) organization. This individual will create, lead and execute technical transfers to and commercial supply from External Partner(s). The candidate will be based in the US and report to the Director, Large Molecule (LM) Drug Product External Manufacturing Technology. The ideal candidate will be someone who can navigate a complex network of drug product nodes across vaccines, and/or biologics modalities and tech support models. The candidate needs to collaborate across multiple technical functions to ensure the success technical transfer and commercial manufacture with the External Partner(s). This individual will be capable of leading several high-impact, complex, cross-functional divisional teams and will provide significant leadership to the department. This role is critical to the organization’s ability to support new and in-line commercial product technology transfers to External Partnerships, and support of our in-line products, with sharp oversight and technical risk management, focus on the rapidly expanding biologics and vaccines third party network.
The Associate Director, Engineering within Large Molecule 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 Large Molecule Focus Factory Operations lead, modality specific Technology Leads, Large Molecule External Quality Assurance, and Procurement.
The primary focus of the Associate Director is to provide technical and project leadership to Large Molecule External Manufacturing business for:
Technical leader and single point of technical contact to assigned External Partners, impacted our Manufacturing Division sites, and Commercialization and Commercial manufacturing of sterile drug product.
Provides leadership, and planning support for complex partnership models. Functions independently and provides coordination, communication, and oversight of assigned External Partner technical issues
Accountable to External Manufacturing for overall tech transfer delivery (on-time, within budget) and commercial manufacturing, working closely with the Operations Unit leadership to assure resourcing for each activity.
Assesses of technology and process proposed by External Partner, verify adherence to required standards, and ensure deliverables are technically sound.
Collaborates with Procurement, External Manufacturing Operations, External Quality, Regulatory and others to evaluate External Partner(s) for inclusion in our Company Network. Executes technical due diligence assessments at External Partner(s).
Ensures tech transfers are positioned for successful business outcomes. Executes technical transfers and receiving site readiness activities.
Leads team for identification and assessment of partner risks and develops mitigations plans.
Develops and executes validation strategies for new and existing products.
Provides manufacturing process support to External Partner(s) to resolve production issues and to provide guidance on process and capacity optimization.
Ensures targeted communications and alignment across technical functions. Guides and coaches others in change leadership.
Support/Coordinate/Manage complex investigations, with appropriate interface with other impacted manufacturing sites
Determines resource plans across all relevant technical functions.
Provides a technical review of External Partner process change requests, deviations, and Master Batch Record changes. Minimizes duplication of efforts between External Partner and our Company systems.
Drive and support Continuous process verification and process performance monitoring program for all products under his/her responsibility
In concert with Commercialization, Quality, and Regulatory, ensures that External Partner(s) are inspection ready for all new product introductions and transfers.
Understands the true regulatory requirements and partners with Operations, Quality, and the External Partner to develop more efficient ways to meet these requirements.
Collaborates with External Partners to achieve business goals and to establish a common culture that benefits both our Company and EP.
Lead critical technical projects relating to the manufacturing of commercial sterile drug product.
This role includes approximately 25% travel.
A Bachelor’s degree in Engineering or applicable Science is required. An advanced degree in Engineering, Science, or Business is preferred.
Minimum of 8 years post-bachelor’s degree or minimum 5 years experience for advanced degrees experience in Drug Substance and/or Drug Product vaccines and/or biologics manufacturing, engineering, and/or technical support of operations is required
Required Skill Requirements:
Experience in manufacturing unit operation design, startup, and/or operation.
Experience in leading cross-functional teams in support of manufacturing operations at internal sites or External Partner(s)
Advanced problem-solving skills and experience leading teams to resolve complex business or technical issues is required
Excellent leadership, collaboration, change management, interpersonal, analytical skills, collaboration, and engagement as a team player with dependable interpersonal and communication skills (both verbal and written) is required.
Preferred Skill Requirement
Experience in Large Molecule unit operation design, startup, and/or operation is preferred.
Experience in complex international environment with matrix organization structures is preferred
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 is preferred.
Creative, innovative, thinks outside of the box, self-motivated, applies problem-solving skills, and solid base in engineering fundamentals and process troubleshooting is preferred
25% for partner assignments outside of primary location. Travel and flexibility in partner assignment location is required; assignments may require short term travel assignments.
Location in U is flexible. Position may be based in West Point, PA or Durham, NC.
This role will report to the Director, Large Molecule Drug Product External Manufacturing Technology
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
Invent. Impact. Inspire.
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.
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