AVP, Plant Manager, Wilmington Biotech

Merck; Wilmington (DE); Hybrid; USD 130,000 - 180,000; Full time

Job summary

A leading company in the pharmaceutical industry seeks an AVP Plant Manager for its Wilmington Biotech facility. The role involves overseeing biologics manufacturing, ensuring compliance with regulations, and leading a diverse team to achieve operational excellence. The ideal candidate will have extensive experience in chemical engineering and a proven track record in manufacturing leadership.

Qualifications

• 10-15 years of experience in a chemical or pharmaceutical manufacturing setting.
• 8-10 years management experience.
• Knowledgeable of all aspects of manufacturing and plant operations.

Responsibilities

• Responsible for planning and directing all activities involved in the manufacture and supply of biologics.
• Sets strategy and direction to achieve Manufacturing, Financial, HR, Quality, and EHS goals.
• Ensures compliance with Good Manufacturing Practices and regulatory requirements.

Skills

Change Management

Chemical Engineering

Lean Process Improvements

Manufacturing Operations Management

Regulatory Compliance

People Leadership

Education

BS Chemical Engineering

Job description

Job Description

Our company's Wilmington Biotech hi-potent biologics manufacturing facility, a new state-of-the-art facility for potent drug substances (DS) and drug product (DP) products, including Antibody Drug Conjugates (ADCs), partnered closely with the Company Research & Development (R&D) Division to commercialize, launch and supply new products with speed, agility and innovation.

Role Description:

The AVP Plant Manager, Wilmington Biotech is responsible for planning and directing all activities involved in the manufacture and supply of biologics drug substance, drug product, warehouse operations, and analytical laboratory operations. Provides direction to the Site Leadership Team, including direct and matrix reports, on the development and delivery of site priorities and site culture. Sets strategy and direction to achieve all Manufacturing, Financial, Human Resources (HR), Quality, Environmental, Health and Safety (EHS), Customer Service, and other continuous improvement goals as set by Company leadership. Responsible for all activities on the plant site and to ensure the site is operated in line with relevant regulations. The Wilmington Biotech Plant Manager is also a member of the Global Biologics Operations leadership team responsible for delivering the OpU strategy.

Primary Activities:
Primary activities include, but are not limited to:

• Responsible for developing and executing a site strategy in line with the Company and Manufacturing Division strategies, focusing on the areas of: Compliance, Supply, People and Cost.
• Through the Integrated Process Team (IPT) Lead/Operations lead, is responsible for a number of complex manufacturing processes that involves production of drug substance and drug product. Ensures all customer service goals are achieved.
• Provides visible leadership, communicates importance of strong EHS and Quality Compliance Culture across the site and establishes a strong compliance culture across the operations
• Through the Quality Lead, and all site functions, ensures the site is operated under current Good Manufacturing Practices and regulatory requirements. Co-chairs the site Quality Council with the Site Quality Lead to monitor and improve operations through System Ownership and Quality Compliance Excellence.
• Through the Finance Lead, and all site functions develops site financial, capital plans and operational objectives in line with Company budget commitments. Monitors activities to ensure compliance with plans, achievement of objectives and compliance with financial controls. Continuously works to improve and optimize financial performance.
• Takes leadership role in management of safety and environmental programs. Through the EHS Lead, and all site functions is responsible for establishing safe and environmentally correct operational procedures and the safety of personnel. Ensures site teams are fully trained and procedures are in compliance with laws, regulations, and Company policies and guidelines.
• Through the HR Lead, responsible for staffing of all positions, ensuring compliance with HR policies, and oversight of all training and labor relations activities. Through all Leadership personnel ensures ongoing employee development and recruitment to achieve business goals and support the Company.
• Through the Director of Supply Chain, connects with upstream and downstream nodes and the regional planning hub to develop and modify production schedules to meet end-market demand and maintain appropriate inventory coverage.
• Represents the Wilmington Biotech site manufacturing for internal governance teams including Global Biologics Operations, R&D Division, regional teams, to external agencies (Quality, S&E, Finance, Supply and HR) and leads and sponsors initiatives as required.
• Partners Collaboratively with relevant leaders and key internal stakeholders (GSEC, Quality, Supply Chain, Technical Operations) to advance the manufacturing site.

Requirements: Qualifications, Skills and Working Conditions

• BS Chemical Engineering, Chemistry, or related field.
• 10-15 years of experience in a chemical or pharmaceutical manufacturing setting.
• 8-10 years management experience.
• Knowledgeable of all aspects of manufacturing and plant operations, demonstrated leadership and team building skills, understanding of business practices, labor relations, as well as excellent communication skills.
• Innovative, with strong focus and proven experience in delivering continuous improvement through Lean Production systems

Current Employees apply HERE

Current Contingent Workers apply HERE

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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, Monday - 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”.

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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:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Required Skills:

Change Management, Change Management, Chemical Engineering, Cross-Cultural Awareness, Customer Service Management, Employee and Labor Relations, Financial Performance, Good Manufacturing Practices (GMP), Human Resources Policies, Interpersonal Relationships, Labour Relations Management, Lean Process Improvements, Manufacturing Operations Management (MOM), Manufacturing Processes, Operational Excellence, People Leadership, Pharmaceutical Manufacturing, Process Improvements, Production Scheduling, Quality Operations, Regulatory Compliance, Regulatory Requirements, Results-Oriented, Self Motivation, Stakeholder Engagement {+ 1 more}

Preferred Skills:

Job Posting End Date:

06/9/2025

*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R349626