Senior Process Engineer, Technical Operations – Small Molecule Drug Product (Oral Solid Dose)
Biopharma Careers
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Benefits offered by this job
Job summary
Biopharma Careers is seeking a Senior Process Engineer, Technical Operations for small molecule oral solid dosage manufacturing in a U.S. facility. You will lead technical workstreams through process transfer, scale‑up, validation, and commercial manufacture, collaborating with R&D and manufacturing teams.
The role emphasizes process ownership, analytical decision‑making, and continuous improvement to ensure quality, safety, and efficiency across the site.
Qualifications
- Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related discipline.
- Typically 5+ years’ experience in oral solid dose manufacturing, formulation, or process development.
- PhD may offset experience.
- Strong experience in OSD manufacturing operations: roller compaction, tablet compression, film coating.
- Experience in process scale-up and commercialization of solid oral dosage forms.
- Involvement in technology transfer, process validation (PPQ), manufacturing support.
- Good understanding of cGMP manufacturing and regulatory expectations.
- Experience troubleshooting tableting and coating processes in a commercial environment.
Responsibilities
- Provide technical leadership for oral solid dose manufacturing processes, including blending, granulation, roller compaction, tablet compression, film coating.
- Act as process owner / SME for assigned unit operations and equipment.
- Support capital projects with equipment selection, CQV, startup readiness for OSD lines.
- Lead or coordinate process scale‑up, technology transfer, and validation activities (PPQ).
- Analyze and interpret process and product data to drive data‑driven decisions.
- Provide advanced troubleshooting for compression, coating issues.
- Lead technology transfers for oral solid dose products into the facility.
- Drive scale‑up strategy, equipment capability, and process comparability assessments.
- Develop master batch records and process descriptions; support integration of new formulations.
Skills
Education
Job description
We have an exciting opportunity for a Senior Process Engineer, Technical Operations – Small Molecule Drug Product (Oral Solid Dose) to join our growing team.
At our company, we aspire to be the premier research-intensive biopharmaceutical company, using the power of leading-edge science to save and improve lives around the world. We are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.
Join a purpose-built, agile small molecule manufacturing site where your work will help bring important medicines to patients in the U.S. This facility is designed to move quickly and reliably, receiving technology transfers from commercialization sites and fast-following into production with a focus on quality, safety, and operational excellence.
At our site, you’ll be part of a team committed to creating a safe, environmentally responsible, and compliant workplace where people can do their best work. We are building deep small molecule expertise in the U.S., and we want team members who are excited to grow their skills, help improve how we operate, and contribute to a site positioned for future growth.
The successful candidate will provide technical leadership and process ownership supporting facility design, commissioning, qualification, and startup through to technology transfer, validation, and ongoing commercial manufacture of oral solid dosage forms.
In this role, you will work as a key member of a cross‑functional team, initially supporting the capital project and transitioning into process lead responsibilities across technology transfer and commercial manufacturing, driving technical excellence and operational performance.
Provide technical leadership for oral solid dose manufacturing processes, including:
- Blending and granulation (where applicable)
- Roller compaction (dry granulation)
- Tablet compression
- Film coating and finishing operations
Act as process owner / SME for assigned unit operations, equipment, or product processes
Provide technical input to the Capital Project Team, supporting:
- Equipment selection and design reviews
- Commissioning and qualification (CQV)
- Startup readiness for OSD manufacturing lines
Lead or coordinate process scale‑up, technology transfer, and validation activities (e.g. process performance qualification – PPQ)
Analyze and interpret process and product data (e.g. blend uniformity, tablet properties, coating performance) to drive data‑driven decision‑making and performance improvements
Provide advanced troubleshooting support for compression, compaction, and coating issues (e.g. weight variability, hardness, sticking/picking, coating defects)
Lead or play a key role in execution of technology transfers for oral solid dose products into the facility
Partner with global R&D and network sites to ensure robust transfer of formulation and process knowledge
Drive:
- Process fit assessments
- Scale‑up strategy from development to commercial scale
- Equipment capability and process comparability assessments
Own or guide development and optimization of:
- Master batch records (MBRs)
- Process descriptions and control strategies
Support integration and industrialization of new formulations and technologies (e.g. continuous manufacturing, advanced granulation approaches where applicable)
Partner with Manufacturing to ensure safe, efficient, and reliable OSD plant performance
Identify, prioritize, and implement improvements in:
- Content uniformity and tablet quality
- Process robustness (e.g. compaction consistency, compression stability)
- Yield, throughput, and cycle time
Lead or drive continuous improvement initiatives aligned with operational excellence
Use structured problem‑solving approaches (e.g. RCA, DOE where applicable) to resolve:
- Compression issues (e.g. capping, lamination)
- Compaction variability
- Coating defects (e.g. color variation, twinning, roughness)
Monitor process trends and product quality attributes to proactively identify risks and opportunities
Contribute to line optimization, changeover reduction, and debottlenecking activities
- Ensure all activities are conducted in compliance with cGMP, safety, and environmental standards
- Provide technical leadership in campaign preparation, execution, and post‑campaign review
- Own and approve batch record updates, process specifications and control strategies
- Support regulatory inspections and audits, providing technical input and ensuring inspection readiness
- Ensure high standards of data integrity and technical documentation
- Act as a technical representative across Manufacturing, Quality, Engineering, Supply Chain, and R&D
- Provide clear technical direction and influence decision‑making across product introductions and commercial operations
- Lead or contribute to cross‑functional initiatives, ensuring alignment to timelines and site objectives
- Support knowledge sharing and best practice transfer across internal and external networks
- Degree in Chemical Engineering, Pharmaceutics, Pharmaceutical Sciences, or related discipline
- Typically 5+ years’ experience in oral solid dose manufacturing, formulation, or process development
- (PhD may offset experience)
- Strong experience in OSD manufacturing operations, particularly:
- Roller compaction (dry granulation)
- Tablet compression
- Film coating processes
- Experience in process scale‑up and commercialization of solid oral dosage forms
- Demonstrated involvement in:
- Technology transfer
- Process validation (PPQ)
- Manufacturing support
- Good understanding of cGMP manufacturing and regulatory expectations
- Experience troubleshooting tableting and coating processes in a commercial environment
- Strong analytical capability with ability to interpret process and product performance data
- Demonstrated ability to lead technical workstreams or projects
- Excellent problem‑solving skills with structured, science‑based approach
- Effective communicator with ability to influence cross‑functional stakeholders
- Proven ability to manage multiple priorities in a dynamic manufacturing environment
- Proactive, self‑driven mindset with strong focus on continuous improvement and ownership
We keep the patient at the heart of everything we do and strive to deliver solutions for some of the world’s most challenging healthcare needs. We believe innovation happens when empowered individuals collaborate in an inclusive, high‑performing environment.
- Adaptability
- Biopharmaceutical Industry
- Change Control Processes
- Chemical Engineering
- Customer‑Oriented
- Deviation Management
- Engineering Standards
- Equipment Selection
- Good Manufacturing Practices (GMP)
- Maintenance Engineering
- Manufacturing Process Validation
- Operational Excellence
- Oral Solid Dosage
- Pharmaceutical Sciences
- Process Optimization
- Regulatory Compliance
- Root Cause Analysis (RCA)
- Strategic Thinking
- Teamwork
- Technical Leadership
- Technical Support
- Technical Transfer
- Technology Transfer
- Vibratory Rollers
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.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
The salary range for this role is $117,000.00 - $184,200.00
Our salary range is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s 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 https://jobs.merck.com/us/en/compensation-and-benefits .
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
Regular
Domestic
No
10%
Not Applicable
Not Indicated
No
n/a
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