Job Description

Director, Platform Lead:Based in Hyderabad, India and reporting to the Executive Director, Global Biologics Operations, the Director, Biologics ExM leads one of the teams with operational and technical responsibility for Drug Substance (DS), Drug Product (DP) and/or secondary packaging with our Supply Partner in Hyderabad. This role is responsible for managing a team of approximately 3-7 direct Full Time Employees (FTEs) and providing overall leadership to the team.Within Biologics Operations, this role is accountable for supplying our Manufacturing Division with quality, cost-effective externally produced products while establishing and maintaining a mutually beneficial business relationship with our external Supply Partner supporting the Large Molecule business. The Director ensures that the sub-processes (DS, DP and/or packaging) for the manufactured products are properly aligned to support the companys strategic direction of enabling Market Access.The role requires the ability to provide guidance on complex technical problems in DS, DP and/or packaging issues that may arise at the Supply Partner. The leader will sponsor the implementation of standard work, driving operational excellence in the technical space, influencing multiple technical and operations stakeholders, and transforming the Ways of Working. This role is critical to the organizations ability to drive efficiencies and effectiveness, increase predictive prioritization in alignment with efficient resource model, and utilizing digital transformation within the technical space in External Manufacturing. As part of the focused factory team, this individual will have key accountability for owning standard work and transformational initiatives that include prospective risk-driven technical decision making.This experienced leader will also have the critical role of defining and standardizing enhanced Contract Manufacturing Operations (CMO) oversight models that are fit-for-purpose with the Supply Partner, and execution that recognizes the complex manufacturing processes across SMEs and aligned quality and technical groups. This individual must be able to lead through uncertainty and leverage the broader Large Molecule network to ensure the right individuals are engaged with clear roles and responsibilities defined. This individual will also partner with the broader Large Molecule network to ensure clear and consistent communications on ExM products across the network.Primary Responsibilities:

• Provide support to the Supply Partner for technology transfers and on-going process support including change control, investigations, capital projects, etc.
• Ensure effective and efficient information transfer/systems between our Manufacturing Division and our Supply Partner, as well as, data management, storage and retrieval, with support by the IT Leader.
• Assist with the resolution of technical and quality issues with the Supply Partner considering the framework of the executed contracts, specifically ensuring the internal quality position is defendable and represents true requirements.
• Prepare and submit an annual budget (profit planning process), provide a monthly estimated actual on the organizations projected and actual spending and maintains a multi-year capital plan/budget for investment at the Supply partner where deemed appropriate (e.g., our Company specific/dedicated equipment, joint investment to augment capacity, create a new capability at the Supply Partner) with the support of Finance.
• Determine resource plans for new programs across all involved functions. Send prioritized signal and resource requests to Centers of Expertise, Subject Matter Experts, and functions across Global Biologics Operations (GBO) and Global Vaccines Operations (GVO).
• Support new ExM project proposals from ideation to deal approval, including support proposal development; proactively manage Supply Partner expectations/requirements through contract negotiations; drive participation in product-focused data acquisition/data sharing initiatives.
• Accountable for supporting the Focused Factory lead in ExM Operations lead in assuring risk identification/mitigation.
• With the broader network, coordinate support for design and execution of capital projects with GSEC.
• Establish and maintain a high performing team organization and culture.

Education:

• Bachelors degree in Engineering, Science, or Business. MS, MBA, or Ph.D. preferred.

Required Experience and Skills:

• 15 years experience and a proven track record in manufacturing, operations and/or adjacent functions
• Expertise in manufacturing of biologics or vaccines drug substance and/or sterile drug product such as fermentation, purification and sterile manufacturing
• Experience in leading cross-functional teams in support of manufacturing operations at internal sites or external partners
• Experience in GMP sterile or biologics/vaccines manufacturing and/or technical support of GMP manufacturing operations.
• Experience with technical transfers.
• Experience in supply chain operations.
• Experience in leading cross-functional teams in support of manufacturing operations at internal sites or external partners.
• Expertise in Lean Manufacturing applications to ensure year on year productivity.
• Must possess excellent leadership, team management, change management, interpersonal, collaboration, negotiation, project management and analytical skills. Including verbal and written communication.
• Must have exemplary people/team leadership experience, including leading and motivating teams. Experienced in establishing performance metrics and holding people accountable for results.
• Demonstrated ability to motivate an organization around a common vision and deliver expected results.
• Experience with local languages is preferred.

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 thats devoted to delivering a high quality, reliable supply to customers and patients on time, every time.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 anothers thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Current Employees applyCurrent Contingent Workers applySearch 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:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements: HybridShift:Valid Driving License:Hazardous Material(s):Job Posting End Date: 07/29/2024*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.

MSD