Site Microbiologist

Job Description

The Site Microbiologist role will involve establishing the Contamination Control Strategy and subsequent Plan at the Wilmington Biotech Campus ensuring the processes conform to our companys policies and comply with cGMPs Health Agency regulations and all other applicable governing regulations with the mission and ambition to manufacture breakthrough medicines from Ireland for patients around the world.

Close collaboration with high performance talent from our companys global team and the biotechnology industry to develop and execute multiple Quality Assurance systems and processes will be key and the successful candidate will inspire the site to build the future of our companys antibody drug conjugates and high potent compounds through a Quality culture that delivers unconstrained supply that is Right First Time to patients worldwide.

Providing training and guidance on the interpretation and implementation of our companys policies and regulatory requirements will also be key priorities for the Associate Director. Throughout the development of the new facility the successful candidate will focus on commissioning qualification and/or validation of the facility equipment and process with focus on contamination control.

The Site Microbiologist will be responsible for supporting the Operations Engineering MS&T and Supply Chain teams ensuring compliance with cGMP and corporate regulations. This is a critical role within the Quality leadership organization to help create value for our patients.

POSITION RESPONSIBILITIES

With energy and enthusiasm the Site Microbiologist will:

a) Acting in the role of Site Microbiologist.

b) Responsible for ensuring that the processes for the manufacture of biologics have been conducted in compliance with GMP the registered marketing authorization and the associated regulatory requirements.

c) In-depth knowledge of US and European GMP guidelines ICH and other international regulatory requirements as applicable to the site.

d) Drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements.

e) Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations.

f) Assisting in and facilitating investigations ensuring effective Root Cause Analysis and CAPAs.

g) Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site.

h) Be an advocate of continuous improvement in the Quality Management Systems.

i) Develop and provide oversite of the Environmental Monitoring program

j) Responsible for the management of the contamination control strategy as well as the contamination control plan.

k) Drives opportunities for continuous improvement.

l) Provide direct audit support and participate in response team for audits and inspections by Health Authorities.

m) Provide support and expertise for the preparation of regulatory submissions inspection readiness activities during health authority inspections including interaction with inspectors responses to inspection observations and monitoring of follow up actions.

REPORTING STRUCTURE

This position will report into the Site Quality Lead

QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS

General

This role requires a seasoned Associate Director with a minimum of 15 years experience in Quality Control Quality Assurance or Pharmaceutical Vaccine or Biological Operations or Technical Operations.

A self-starter and results-focused the successful candidate will have strong contemporary knowledge of relevant cGMPs regulations and current industry trends.

Technical

• Must have at least 5 years of operational experience in a regulated environment.

• Must have 4 years experience in Sterility Assurance or aseptic Drug Product manufacturing (liquid and lyophilized product) including clear understanding of aseptic processing requirements (including Annex I).

• Preferred to have experience in manufacturing low bioburden Drug Substance

• Demonstrated knowledge of Cleaning in Place Sanitize in Place and Aseptic Process Simulation.

• Demonstrated understanding of continuous quality / process improvement tools (As defined by the site e.g. DMAIC Lean QA 5S etc).

• Exceptional analytical problem solving & root-cause analysis skills.

• Ability to multi-task and handle tasks with competing priorities effectively.

• Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures) global regulatory experience & experience interfacing with regulators is preferred.

• Strong operations support background ensuring value added and effective quality oversight

• Previous experience in site microbiologist role preferred.

• Capital Project experience preferred.

• Direct experience in antibody drug conjugate manufacturing preferred.

People

• A great communicator decisive decision maker and proven ability to deliver excellence

• Strong contemporary knowledge of relevant cGMPs regulations and current industry trends related to aseptic drug product manufacturing.

• Experience with new product introductions and/or process qualification/technology transfer

• Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA) complaints & risk management; & product quality improvement using tools such as six sigma DFR etc.

• Excellent communication skills (written and oral).

• Required to work on his/her own initiative in addition to working as part of and leading a team. Must be able to work across a team matrix to meet accelerated timelines.

• Desire to continuously learn improve and develop.

• Ability to facilitate groups with diverse perspectives and influence and bring teams to consensus and alignment.

• Effective communication presentation and interpersonal skills to interface effectively with all levels of colleagues and with external customers in a team orientated manner.

• Able to demonstrate good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions; communicates influences and escalates issues and decisions as needed.

• Planning and scheduling skills Proven organizational skills Flexible approach.

• Goal/results orientated Starter/Finisher.

Education

• Bachelors degree (or higher) in Chemistry Biology Microbiology Automation Engineering or in a relevant discipline the successful candidate will also ideally have a proven track record in delivering excellence.

• The candidate will also show ambition and drive to develop and advance their career within our company.

Required Skills:

Preferred Skills:

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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 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.

The salary range for this role is

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 employees 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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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.

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