Job Description

We are currently seeking an Associate Principal Scientist/Engineer for our Pharmaceutical Commercialization Technology (PCT) team. PCT is responsible for pharmaceutical process development of primarily oral solid dosage forms from Phase IIb through regulatory filings, process performance qualification, and into commercial supply. Our work is supported by development facilities in West Point, PA, and Rahway, NJ, a primary commercialization site in Ireland, and a global network of internal and external supply sites.

The Associate Principal Scientist will serve as a key technical and business leader, overseeing process development activities for a segment of the late-stage pharmaceutical project portfolio. This role leads teams responsible for creating and executing process development plans, aligning with clinical supply plans, developing, and documenting the knowledge base needed for regulatory filings, and managing the project through early launch and supply steps. The Associate Principal Scientist also ensures that interfaces with relevant partner groups - upstream, downstream, and parallel are managed collaboratively, efficiently, and effectively.

The successful candidate may lead high-impact, complex, cross-functional teams and initiatives. The Associate Principal Scientist will champion cultural change to support and realize PCT's and our Company's vision, driving technical excellence and understanding. The Associate Principal Scientist should have fluency in risk-based approaches to development, design of experiments, and process modeling. Proficiency in scientific writing is essential for preparing technical reports and authoring CTD sections to support product registration efforts.

Primary activities include, but are not limited to:

Advance the pipeline:

• Decides on development plans and outcomes for Final Market Formulations and commercial processes
• As project team leader, develops high-performing teams, or as a key member of multiple smaller teams influences direction for optimal solutions based on use of systematic planning, risk, and options analysis tools. Escalates issues appropriately for visibility and resolution

Technical expertise and technology development:

• Acts as Subject Matter Expert (SME) in technical areas to efficiently solve problems using appropriate tools and prior knowledge.
• Has fluency of scientific/technical concepts and techniques, applies and furthers those concepts and techniques in pursuit of resolving scientific/technical issues.
• Supports technical capability build and knowledge sharing within organization
• Technical depth and breadth in all aspects of solid dosage form and process development, including standard and enabled formulations and processes, characterization techniques, experimental data analysis and modeling, including statistical and first principal approaches.
• Leads application of process development in accordance with ICH principles in regulatory filings, with an emphasis on process robustness and flexibility with business benefits using enhanced and traditional control strategies.

Build capability and strategic thinking:

• Makes informed cost/benefit decisions based on analysis of inputs, risk and likely return, and takes ownership of the outcomes.
• Influences departmental strategy and tactics, particularly with regard to technical issues
• Leverages communication mechanisms and business processes to facilitate decision making and leverages the collective experience of the organization
• Influences interactions with key partner groups, and helps to set strategy and tactics across functions

Minimum Required Education and Experience:

• Bachelor of Science (BS) in Engineering, Chemistry, or related engineering/scientific discipline with seven (7) years' experience in oral solid dosage drug product development or closely related area; OR
• Master of Science (MS) in Engineering, Chemistry, or related engineering/scientific discipline with five (5) years' experience in oral solid dosage drug product development or closely related area; OR
• PhD in Engineering, Chemistry, or related engineering/scientific discipline with two (2) years' experience in oral solid dosage drug product development or closely related area

Required Skills and Experience:

Depth of experience in one or more of the following areas:

• Spray Drying for Amorphous Solid Dispersions
• Bilayer Compression
• Process or formulation development for Peptide drug products and/or formulations using permeation enhancement
• Discrete Element Modelling (DEM)

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US and Puerto Rico Residents Only:

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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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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R338070