Assoc. Dir, External Manufacturing

MSD; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a highly motivated Associate Director of Technical Operations to enhance drug substance manufacturing within their External Manufacturing Network. This role offers a unique opportunity to lead technical initiatives, collaborate with external partners, and drive continuous improvement in manufacturing processes. The ideal candidate will possess strong problem-solving skills and a proven track record in drug substance commercialization. Join a dynamic team committed to delivering excellence and innovation in the pharmaceutical industry, where your contributions will make a significant impact on high-visibility projects.

Qualifications

• 7+ years of experience in manufacturing, including process startup and technical transfer.
• 5+ years in drug substance with experience in new product introduction.

Responsibilities

• Lead technical interface between operations and external partners.
• Provide technical guidance and ensure adherence to standards.
• Support and manage complex investigations and technical transfers.

Skills

Drug Substance Manufacturing

Technical Transfer

Process Development

Problem Solving

Stakeholder Management

Leadership

Quality Systems

Root Cause Analysis

Education

Bachelor's Degree in Engineering or Chemistry

Tools

Lean Manufacturing

Six Sigma

Project Management

Job description

Job Description

Our Small Molecule Technical Operations Unit is seeking a highly motivated individual to fill an open Associate Director Technical Operations, to support drug substance manufacture within our External Manufacturing Network. This is an exciting opportunity to work with key strategic external partners, contribute and enhance technical experience in drug substance manufacturing, and work on high visibility network initiatives. Our team strives to provide technical excellence in our work and be strong partners, collaborators, and leaders within the small molecule line of business at our company.

Our team of chemists and engineers help ensure that external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

Primary responsibilities for this position include, but are not limited to, the following:

• Lead and act as the primary interface on technical issues between technical operations and the external partner.

• Provide technical leadership within the technical operations group for the commercialization and manufacture of drug substance.

• Provides technical guidance to the external partner, assesses viability of technology in proposed process configurations, verifies adherence to required standards, and ensures deliverables are technically sound.

• Collaborates with external manufacturing operations, external quality, regulatory, and others to evaluate external partner(s) performance, fostering pro-active risk management mindset and continuous improvement

• 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.

• 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.

• Supports/coordinates/manages complex investigations, with appropriate interface with other impacted manufacturing sites.

• 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 systems.

• Drives and supports continuous process verification and process performance monitoring program for all products under his/her responsibility.

• Understands the true regulatory requirements and partners with operations, quality, and the external partner to develop more efficient ways to meet these requirements.

Education and Minimum Requirements:

• Bachelor’s degree in engineering, chemistry sciences or related discipline with a minimum of 7 years of relevant work experience in manufacturing, in the areas of process start up, routine manufacturing and/or technical transfer

Required Skills and Experience:

• Minimum of 5 of experience in drug substance with experience in leading Drug Substance new product introduction, technical transfers, commercial manufacturing
• Demonstrated knowledge and experience in process development, scale up and process robustness, including shop floor (person in plant) support.
• Strong problem-solving skills, root cause analysis and risk assessment/mitigation
• Ability to work effectively across boundaries to build strong collaborative relation with internal and external teams, to drive alignment and results
• A high level of effectiveness in professional and interpersonal communication skills, including stakeholder management, are required.
• Authentic and inclusive people leadership, able to provide examples of your ability to engage and create a psychologically safe and collaborative culture.
• Must be able to work under own initiative, prioritise appropriately based on business need and work within tight deadlines.
• Flexibility and the ability to work independently as well as excellent organizational skills.
• Strong knowledge of quality systems, drug substance manufacturing and validation.
• Excellent command of English (both written and oral).
• Travel will be a requirement of this position at approximately 25%

Preferred Experience and Skills:

• Knowledge and experience of flow chemistry, enzyme manufacture and bio-catalysis are desirable but not essential.
• Lean Manufacturing / Six Sigma Experience
• Project management experience
• Knowledge of worldwide regulatory requirements, experience supporting regulatory inspections.

Current Employees apply HERE

Current Contingent Workers apply HERE

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Remote

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

05/16/2025

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