Associate Director, Process Engineer - Oral Solid Dosage, Clinical Manufacturing (Onsite)

Job Description

Position Description:

Associate Director, Process Engineer - Oral Solid Dosage, Clinical Manufacturing

The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey. 

This team works with non-sterile formulations, typically oral solid dosage (blending, roller compaction, encapsulation, tableting) though also including spray dried intermediates, liquid suspension/bottle fills, and autoinjector assembly. We are part of the research division, focusing on development and clinical deliveries in a GMP piloting facility supporting our company's research division.

The Oral Solids Dosage (Non-Sterile) team at the FLEx Center in Rahway is looking for an Associate Director – Process Engineer to lead clinical supply manufacturing, scientific rigor of processes, and ultimately to enable flexibility and speed of our company's pipeline.

This person will:

• Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products.

• Manage a team of 2-5 process engineers by coaching and developing for success through feedback and development guidance.

• Review and approve GxP documentation including but not limited to batch records, specification, equipment qualifications, change records and deviations.

• Build partnerships by developing and leveraging relationships within and across work groups of formulators, engineers, safety and quality representatives.

• Foster culture of collaboration, learning and innovation.

• Support in setting specific and measurable short- and long-term goals.

Position Qualifications:

Education Minimum Requirements:

• Associate’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related field with a minimum of 12 years relevant experience

• Bachelor’s in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 10 years relevant experience

• Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 8 years relevant experience

• PhD in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 5 years relevant experience

Required Experience and Skills:

• Experience leading GxP manufacturing in pilot plant environment.

• Experience reviewing and approving GxP documentation, quality investigations and change management.

• Extensive knowledge and experience of drug product processing.

• Managing and developing team including identifying and assessing goals, creating a learning environment and monitoring progress of growth.

• Familiarity with US and EU GMP and Safety compliance regulations.

• Desire and willingness to learn, contribute and lead through independent problem-solving.

• Effective interpersonal and communication skills, both verbal and written.

Preferred Experience and Skills:

• Knowledge of Investigational drug regulatory requirements

• Audit experience: safety, environmental, compliance/quality

• Understanding of Clinical Supply Chain Operations

• Experience with Commissioning, Qualification and Validation

• Experience with spray dried intermediates and/or hot melt extrusion

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace.  All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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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 another’s thinking and approach problems collectively.

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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”.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

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

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:

Relocation:

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