Sr. Specialist, Process Engineering Oral Solid Dosage, Clinical Manufacturing (Onsite)

Job Description

Job Description:

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. The Non-Sterile Process Engineering team ensures right-first-time manufacture and delivery of high-quality drug products (spray-dried intermediates tablets and capsules) leveraging pharmaceutical unit operations such as spray-drying hot-melt extrusion blending roller compaction encapsulation compression and film coating. We are part of our Companys research division focused on development and clinical deliveries in a GMP pilot facility supporting partners in Oral Formulation Sciences and Pharmaceutical Commercialization Technology to enable faster delivery of new medicines to clinical trials.

The Non-Sterile (Oral Solids Dosage) team at the FLEx Center in Rahway is looking for a Sr. Specialist - Process Engineer to lead clinical supply manufacturing with scientific rigor of processes to ultimately enable flexibility and speed of our companys pipeline.

This person will:

• Lead on-the-floor batch manufacturing in a pilot plant while prioritizing and ensuring safety and quality of clinical supplies.

• Author and review GxP documentation including but not limited to batch records specifications equipment qualifications change records and deviations.

• Facilitate and support early process development by assisting in lab activities and sharing knowledge transfer for scaling at pilot plant scale with relevant partners via technical reports and presentations.

• Propose new innovative approaches for enhanced product understanding and/or process development generate experimental designs execute experimental plans and interpret data.

• Support process development activities using Design of Experiments for new chemical entities or life cycle management opportunities.

• Identifies and resolves technical and operational problems; collaborating with peers to resolve problems that cross into inter-related units

• 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.

Required Experience and Skills:

• Proven ability to identify and develop innovative ideas.

• Strong problem-solving skills and a direct involvement approach to problem solving Candidate should be able to examine an issue from diverse perspectives (safety compliance automation equipment process and people) to best understand and identify root cause

• Demonstrated ability to independently design and execute complex experiments and analyze data.

• Familiarity with GMP and safety compliance regulations.

• Ability to work effectively with team members of diverse skill sets and backgrounds.

• Strong interpersonal and communication skills both verbal and written.

Education Minimum Requirements:

Bachelor of Science degree in Chemical Engineering Biomedical Engineering Chemistry Pharmaceutical Sciences or related scientific field with minimum of 5 years relevant experience or a Masters degree with 3 years of relevant experience or a PhD degree (with expected completion no later than June 2026).

Preferred Experience and Skills:

• Pharmaceutical development experience.

• Demonstrated ability to identify fundamentally characterize and address manufacturing challenges through the development optimization and execution of novel production technologies.

• Experience with small molecule drug product manufacturing technologies including: blending granulation compression encapsulation film coating spray drying and hot-melt extrusion.

• Experience with process modeling simulation and automation integration in the pharmaceutical and/or industrial manufacturing sector.

• Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies.

• Demonstrated ability to apply the principles of physical/organic chemistry physical pharmacy and materials science to solving practical pharmaceutical development problems.

• Hands-on experience in pharmaceutical manufacturing plants.

Schedule:

This role supports operational coverage across multiple shifts. Candidates must be willing and able to float between 1st and 2nd shift.

Work schedules for this role will vary based on the needs and timing of assigned campaigns. While standard working hours will apply most of the time there may be occasions when you are required to work earlier later or extended hours to support campaign requirements. Reasonable notice of schedule changes will be provided whenever possible.

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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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