Associate Director, Process Validation and Tech Transfers

Wave Life Sciences; Lexington (MA); On-site; USD 170,000 - 230,000; Full time

Benefits offered by this job

Company-sponsored medical, dental, and vision insurance

Generous paid time off

401K participation with matching contributions

Employee Stock Purchase Program

Job summary

Wave Life Sciences is looking for an Associate Director of Process Validation and Tech Transfers in Lexington, MA. This pivotal role involves leading process validation, ensuring compliance with cGMP standards, and collaborating with cross-functional teams for technology transfers. The ideal candidate will have extensive experience in oligonucleotide manufacturing and a solid educational background in biochemistry or related fields.

Responsibilities include authoring validation documents, overseeing PPQ activities, and acting as the technical expert during regulatory audits. The position offers a competitive salary and comprehensive benefits, making it a great opportunity to make significant contributions to RNA medicine development.

Qualifications

• M.S. or Ph.D. degree in biochemistry, chemistry, or engineering preferred.
• 8+ years of bio-pharma manufacturing industry experience in a cGMP environment.
• Oligonucleotide manufacturing and PPQ experience required.

Responsibilities

• Lead and oversee the implementation of validation master plans and process validations.
• Author, review, and approve technical documentation including validation protocols.
• Collaborate with QA, manufacturing, and development teams for technology transfers.

Skills

Expert-level proficiency in solid-phase synthesis

Hands-on experience with ASO, siRNA

Thorough understanding of 21 CFR Part 11 and ICH guidelines

Education

M.S. or Ph.D. degree in biochemistry, chemistry, or engineering

Tools

UNICORN software

Job description

Associate Director, Process Validation and Tech Transfers

Lexington, MA, United States

Job Description

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities including RNAi silencing and RNA editing provides us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline is focused on our obesity, alpha-1 antitrypsin deficiency and PNPLA3 I148M liver disease programs and includes clinical programs for Duchenne muscular dystrophy and Huntington’s disease, as well as several preclinical programs utilizing our versatile RNA medicines platform. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description

The Associate Director, Process Validation and Tech Transfers plays a critical role in leading and overseeing the development, implementation, and maintenance of validation master plans, process performance qualifications (PPQ), and continued process verification (CPV). This individual is responsible for guiding process validation studies, particularly those specialized in oligonucleotides and siRNAs, ensuring all activities comply with cGMP, FDA, ICH, and ISO standards. Serving as the technical subject matter expert during regulatory audits and inspections, the Associate Director bridges process development with at-scale GMP manufacturing at contract development and manufacturing organizations (CDMOs). The role involves authoring, reviewing, and approving technical documentation, including validation protocols, reports, and risk assessments, while also leading investigations into process failures and deviations. The Associate Director collaborates closely with manufacturing, QA/QC, and development teams for technology transfer, equipment qualification, and provides technical expertise to manufacturing technicians. Maintaining strict quality standards and cGMP practices throughout the process, this position acts as a liaison between Process Development and Manufacturing, supporting the scale-up of existing processes to manufacturing‑ready levels.

Experience

• M.S. or Ph.D. degree in biochemistry, chemistry, or engineering is preferred, or equivalent work experience
• 8+ years bio-pharma manufacturing industry experience in a cGMP environment
• Oligonucleotide manufacturing and PPQ experience is required
• Develops, implements, and maintains the Validation Master Plan (VMP) and associated documents and strategies for process transfers and scale‑up, cleaning, and equipment validation (external).
• Supports the planning, execution, and documentation of PPQ batches, managing risks and technical transfer activities from Process Development to commercial Manufacturing or Contract Development & Manufacturing Organizations (CDMOs).
• Collaborates with Process Development to author and review CMC technical documentation, including validation protocols, reports, and data submissions, ensuring alignment with regulatory expectations and cGMP.
• Supports and reviews Continued Process Verification plans, monitors critical process parameters (CPPs) and Critical quality attributes (CQAs), and utilizes statistical tools for data trending to maintain a state of control.
• Reviews validation investigations, root cause analysis for process failures, and manages corrective and preventive actions (CAPA) to improve reliability.
• Represents the validation function during internal, customer‑facing, and regulatory inspections, defending validation strategies.
• Partners with Quality, Regulatory Affairs, and CDMO partners to facilitate audit readiness and technical transfer.
• Collaborates with cross‑functional teams during all stages of validation‑related activities, such as Validation Master Plan (VMP), including but not limited to FMEA, PPQ, QbD, and CPV.
• Reviews “recipes” (method files) on the OligoPilot 400 (OP‑400), Purification and Lyophilization unit operations for accuracy and GMP compliance.

Responsibilities

May include some or all of the following:

• Manages the transition from bench‑scale (1-4 mmol) to the OP-400 (25-100 mmol) and potentially commercial scale manufacturing. Supports DoE (Design of Experiments) to determine the "proven acceptable ranges" (PAR) for synthesis and purification for PPQ readiness.
• Supports the transfer of siRNA processes to CDMOs during pre‑PPQ and PPQ activities.
• Reviews Master Batch Records (MBRs), SOPs, and Campaign Summary Reports as needed.
• Provides support to manufacturing associates in the production of oligonucleotides, including synthesis, C&D, purification, desalting, and lyophilization.
• Identifies and initiates process deviations during the GMP tech transfers, investigations, and CAPAs during external GMP manufacturing.
• Supports continuous improvement initiatives by identifying improvement areas, recommending strategies, and helping to implement those strategies once approved.
• Reviews and records methods, materials, and results in batch records according to established formats during tech transfers.
• Serves as primary contact for reviewing GMP manufacturing records to ensure proper process transfers internally and externally (CMOs).
• Performs technical review of batch records and process instructions internally and externally (CMOs).
• Participates in meetings to identify and troubleshoot manufacturing issues internally and externally (CMOs).
• Drafts technical sections for regulatory filings (IND/NDA), specifically focusing on Module 3 (Drug Substance).
• Expert‑level proficiency in solid‑phase synthesis and UNICORN software (used by OP‑400) preferred, and recipe writing experience is must.
• Hands‑on experience with ASO, siRNA (double‑stranded RNA), and the specific challenges of RNA stability and duplexing.
• Thorough understanding of 21 CFR Part 11 and ICH guidelines (Q7‑Q11).

Key Skills

• Expert‑level proficiency in solid‑phase synthesis and UNICORN software (used by OP‑400) preferred, and recipe writing experience is must.
• Hands‑on experience with ASO, siRNA (double‑stranded RNA), and the specific challenges of RNA stability and duplexing.
• Thorough understanding of 21 CFR Part 11 and ICH guidelines (Q7‑Q11).

Pay Range External Disclosure Statement

The annual base salary range for this position is $170,000 - $230,000.

The range provided is based on what we believe is a reasonable estimate for the annual base salary pay range for this position at the time of posting. Actual annual base salary will vary based on several factors including, but not limited to, relevant skills, experience, qualifications, position criticality, and internal equity. This position is eligible for a discretionary annual bonus and discretionary stock‑based long‑term incentives. In addition to compensation, Wave offers a comprehensive and competitive range of benefits designed to support our employees and their families physical and financial health and overall well‑being. These include, but are not limited to, company‑sponsored medical, dental, vision, life, long and short‑term disability insurances, generous paid time off (including a week‑long company shutdown in the Summer and the Winter), 401K participation with matching contributions, and Employee Stock Purchase Program.

Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.