Analytical Scientist II/QC Manager, External Operations

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 includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, and obesity. 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

Wave seeks a highly motivated professional with expertise in analytical chemistry and quality control to join a growing Quality Control department in Lexington, MA. The Analytical Scientist/QC Manager, External Operations is responsible for supporting and managing analytical methods transfer, validation, reporting and ongoing testing and characterization activities at Wave’s external partners. The responsibilities will span from Phase I through to Phase III/NDA and into commercial. With successful clinical readouts in DMD and HD, initial emphasis for this role will be on advancing these programs through NDA filing and commercial registrations. This role is a newly created position in a growing Analytical/QC department within CMC operations at Wave. The position works with multiple functional groups including AD/QC (Analytical Development/Quality Control), MS&T (Manufacturing, Science, and Technology), PD (Process Development), DPTS (Drug Product Technical Services), Regulatory CMC, and Quality to drive CMC activities to completion and ensure compliance with internal and external requirements.

The successful candidate is self-motivated, independent, highly organized, and able to thrive in a team-oriented, fast-paced cross-disciplinary biotech environment. Initial emphasis of this role may be on Wave’s late stage DMD and HD assets to ensure successful NDA filing. This is an ideal position for an individual to apply their expertise in late-stage drug development to cutting edge RNA-based drug modalities including Exon skipping, siRNA and our first-in-class RNA editing therapeutic platform. Availability to work in-person 3 days per week in a hybrid working model with on-site Wave operations team members is preferred.

Responsibilities

Support transfer of Wave’s analytical methods and associated CMC documents and materials for DS and DP to external Contract Manufacturing and Contract Testing partners (CDMO’s and CTL’s)

Manage and track delivery, review and approval of technical protocols, reports and related analytical/CMC documents to support advancing analytical and QC activities

Assist in management, delivery and tracking of critical samples, reference materials and related supplies

Author and/or review applicable QC/CMC related sections of regulatory filings and engage closely with Wave’s regulatory colleagues

Active and timely support for troubleshooting and related technical improvements.

Review and monitoring of test data, communication of key results with internal and external stakeholders

Review and contribute to specifications, batch records, certificates, investigations, deviations and change controls

Navigate between Wave analytical and QC expertise and external counterparts

Provide needed technical subject expertise and document support for process validation (PPQ) activities for DS and DP

Work collaboratively within multi-disciplinary internal teams and manage a complex mixture of near-term and long-term deliverables

Occasional travel to domestic or international CDMO’s to support project needs

May contribute to Wave internal analytical, QC and related laboratory CMC operations and objectives

Follow all applicable company SOPs, work instructions and guidelines

Experience and Key Skills

Bachelor’s, Master’s, or PhD degree in related field with minimum 8 years of experience in Pharmaceutical Industry in a relevant CMC-related role such as analytical development, quality control, stability, regulatory, quality, manufacturing

Significant attention to detail is required as this position will author/review technical documents, reports and data sets that support clinical trial and product registration.

Expertise in late-stage drug development, with emphasis on NDA preparation, PPQ studies and commercial registration

Expertise with oligonucleotide or peptide products and regulatory starting materials thereof is preferred but not required

Direct experience with analytical lab techniques including HPLC, LC-MS, UV-Vis, microbiology and/or other wet chemical or biochemical methods in a GMP environment is highly preferred

Expertise in establishing and managing relationships and budgets with contract testing labs

Extensive expertise in MS Word, Excel, Power Point and Quality documentation platforms to produce high quality documents

Project and meeting management skills

Ability to identify technical or logistical challenges and suggest resolutions

Excellent organizational, interpersonal and decision-making skills, as well as verbal and written communication skills

Familiarity with domestic and international regulations and GMP guidelines relevant to analytical development, QC and broader CMC

Comfortable in a fast-paced environment and able to navigate changing priorities

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.

We value our relationships with professional recruitment firms. To protect the interests of all parties, and, given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.