Manager, Process Engineering

Position Summary

The Manager, Process Engineering, will serve as Revision's technical lead for moving formulations from development into commercial-scale manufacturing, for maintaining the manufacturability of products already on the market, and tech transfer between CDMOs.

This role owns end-to-end technical transfers between CDMOs - including transfers of new products into initial manufacturing, and transfers of existing products from one CDMO to another - along with the scale-up activities, engineering and validation batches, and documentation required to bring each transfer to a successful, audit-ready close.

This individual will also lead process validation for OTC products in accordance with FDA monograph and cGMP requirements and will serve as the technical owner for assessing and managing the impact of raw material changes, substitutions, and supplier transitions on marketed products.

The Manager will work closely with Research & Clinical Development, Quality, Regulatory Affairs, Supply Chain, and our CDMO partners to ensure that every transfer, scale-up, and validation activity is executed on time, in compliance, and without disruption to product supply.

Key Responsibilities

1. Technical Transfer & CDMO Management

• Lead end-to-end technical transfer of formulations and manufacturing processes between CDMOs, including transfers of new products into first manufacture and transfers of established products from one CDMO to another.
• Serve as the primary technical point of contact for CDMO partners throughout transfer, scale-up, and commercialization activities.
• Develop and execute technical transfer protocols, risk assessments, and transfer plans consistent with ICH Q8/Q10 principles and Revision's quality standards.
• Coordinate engineering/qualification runs and GMP validation batches at receiving sites, and compile technical transfer reports documenting outcomes and any process adjustments.
• Support evaluation and qualification of new CDMO partners as needed for business continuity, cost optimization, or capacity expansion.

1. Scale-Up & Process Engineering

• Lead scale-up of formulations from lab/pilot scale to commercial manufacturing scale, identifying and resolving differences in equipment trains and critical process parameters.
• Partner with Formulation Science/R&D to translate bench-scale processes into robust, reproducible commercial manufacturing procedures.
• Troubleshoot manufacturing and process deviations that arise during pilot runs, scale-up, and commercial production.
• Apply process engineering principles - mixing, mass transfer, homogenization, emulsification, and similar unit operations - to optimize yield, consistency, and manufacturing efficiency.

1. OTC Validation & Regulatory Compliance

• Lead process validation for OTC drug products in accordance with FDA OTC monograph requirements and cGMP regulations.
• Partner with Quality and Regulatory Affairs to ensure validation protocols, master batch records, and specifications meet OTC compliance requirements.
• Support all three stages of the process validation lifecycle: Process Design, Process Qualification, and Continued Process Verification.

1. Marketed Product Support & Raw Material Change Management

• Assess the technical and manufacturing impact of raw material changes, substitutions, and discontinuations on marketed products, and lead qualification of alternate suppliers or materials.
• Manage change control for formulation, process, or supplier changes affecting commercial products.
• Partner with Supply Chain and Procurement to proactively flag supply risk and support contingency or dual-sourcing strategies.
• Provide technical troubleshooting and root cause analysis for manufacturing or quality issues affecting marketed products.

1. Cross-Functional Leadership

• Partner closely with RCD, Quality, Regulatory, Supply Chain, and Operations to align on technical transfer timelines, scale-up milestones, and validation deliverables.
• Serve as a key partner in the Technical Services Team at Revision Skincare, led by the Project Manager.
• Communicate technical transfer and validation status to Executive Leadership.
• May supervise process engineers or technical transfer staff as the team grows.

1. Documentation & SOP Management

• Develop, review, and update standard operating procedures (SOPs), work instructions, and batch records to reflect current processes and align with cGMP and internal quality standards.
• Support the Quality organization in maintaining SOPs in an audit-ready, compliant state, ensuring all changes are captured through appropriate change control.
• Ensure technical transfer, scale-up, and validation activities are documented in controlled procedures consistent with regulatory expectations.

Qualifications & Experience

We are seeking a hands-on technical leader who can bridge formulation science, manufacturing, and quality to keep products moving smoothly from development through commercial supply.

The ideal candidate will have:

1. Bachelor's degree in Engineering including, Chemical Engineering, Industrial Engineering, Mechanical Engineering or a related technical discipline required; advanced degree preferred.
2. 7+ years of experience in process engineering, technical transfer, or manufacturing within cosmetics, OTC drug, pharmaceutical, or CDMO environments.
3. Demonstrated experience leading technical transfers between CDMOs, including engineering/qualification runs and GMP validation batches.
4. Strong understanding of FDA OTC monograph requirements, cGMP regulations, and process validation (Stages 1-3).
5. Experience with scale-up of emulsions, creams, serums, or similar topical formulations strongly preferred.
6. Experience managing raw material changes, supplier qualification, and change control for marketed products.
7. Strong project management skills, with the ability to manage multiple concurrent transfer and validation projects.
8. Excellent written and verbal communication skills, with the ability to convey technical information to cross-functional and executive stakeholders.
9. Proficiency with process engineering and statistical tools (e.g., Minitab) preferred.
10. Willingness to travel to CDMO and manufacturing sites as needed.

Leadership Competencies:

• Initiates and drives changes related to marketed products
• Speaks up and has a point of view even when it is unpopular and can handle their own when challenged
• Knows when to get into the details and "roll up your sleeves" to help with tactics
• May supervise a professional staff
• Works cross organizations and with global partners

Travel:

• This position will require up to 30% of travel to CDMO and manufacturing sites.

Position is commensurate with experience.

Physical Requirements and Work Environment

This role requires the ability to perform standard office activities, including extended periods of computer use, participation in virtual and in-person meetings, and collaboration across teams. Depending on business needs, occasional travel may be required. Work environments and physical requirements may vary based on the requirements of the role. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.

This job description describes the general nature and level of work performed and is not intended to be an exhaustive list of all responsibilities. Duties and responsibilities may be modified, added, or removed as necessary to meet business and organizational needs.

Benefits

Revision Skincare® offers competitive compensation, annual incentive opportunities, and comprehensive benefits, along with meaningful opportunities for growth, development, and collaboration in an inclusive and innovative environment.

Work Authorization

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the United States.

Next Steps

• If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
• The next step is a virtual conversation with the hiring manager
• The final step is a panel conversation with the extended team

Don't meet every single requirement? At Revision Skincare®, we are dedicated to building a diverse, inclusive, and innovative workplace. If you're excited about this role, but your experience doesn't align perfectly with the qualifications listed, we encourage you to apply anyway!

If you are considering employment at Revision Skincare®, review our job postings at revisionskincare.bamboohr.com/careers. Please be aware of fraudulent job offers and individuals falsely claiming to represent our Human Resources department. Our company will never request or offer payment, personal financial information, or sensitive data (such as Social Security numbers or bank details) during the early stages of recruitment. All legitimate communications from our HR team will come from official company email domains and follow our established hiring process.