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 of DPTS leads drug product (DP) validation activities for Wave’s injectable assets in Phase 1-3 clinical trials and authoring of documents required for Regulatory submissions. This role supports formulation activities to produce viable drug product (DP) presentations for phase appropriate clinical studies and manages tech-transfer activities to CMO organizations to ensure sufficient GMP DP supply for clinical trials in conformance with applicable Standard Operating Procedures (SOPs), Wave standards, industry best practices, and regulatory requirements. The role requires cross-functional influence to progress DPTS deliverables of Wave assets to maintain Wave’s aggressive timelines. Experience: S. or Ph. D. degree in Pharmaceutical Sciences, Chemistry or Engineering is preferred OR equivalent work experience 8+ years Bio-Pharma industry in Aseptic Drug Product GMP environment with PPQ campaign experience required Experience of authoring DP sections of CTA/IND/NDA/BLA submissions required Experience in Oligonucleotide Manufacturing and Managing CMOs desirable Experience with Pre-filled syringes and/or autoinjectors desirable Responsibilities: May include some or all of the following: Plan and execute DP formulation development studies to select Phase appropriate DP Presentation Initiate/Oversee PPQ activities at CMO ensuring commercial readiness for DP Author DP sections of Regulatory submissions and provide timely responses to their questions Ensure effective and efficient tech-transfer and GMP manufacturing of oligonucleotide adhering to strict quality standards at Wave and CMO sites Function as interface/liaison between Process Development, Analytical, Quality, Regulatory and Supply Chain departments Supports continuous improvement initiatives by identifying areas needing improvement and communicating strategies for improvement Respond quickly and effectively to multiple and changing priorities, and to schedule work effectively to ensure that current and future needs are met Technical review of batch records and process instructions internally and externally (CMOs) Manage CMO relationships to ensure sufficient Drug Product supply of Wave Assets for clinical and commercial supply. Key Skills: Experience in DP formulation development of liquid and lyophilized presentations including Drug delivery systems and combination products desirable Strong scientific authoring experience and excellent communication skills required Practical knowledge of cGMP regulations required Ability to effectively manage time and prioritize tasks independently in a fast-paced environment Proficient with MS Office Word, Excel, PowerPoint Must be self-motivated, able to work independently, and have a proven ability to work in a team environment Pay Range Disclosure Statement $163,000 — $221,000 USD 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. 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. Data Privacy and Your Information By submitting your information in applying for a position at Wave (or lawfully on behalf of a candidate as an approved recruiter), you represent that the information you submit (including your name, phone number, email address, address, and resume/CV/work history) is true and accurate, you have the right to share it, and that no part of the Information violates or infringes the rights of any third parties. If you submit information lawfully on behalf of another applicant as an approved recruiter, you confirm that you have the right to so submit. You grant Wave permission to use your information to contact you in connection with this or another position, for interviews, scheduling purposes, travel arrangements, or follow up after a decision on the role has been made. Wave Life Sciences is committed to respecting your privacy. We do not sell or rent personal information to third parties for marketing purposes. Any Personal Information you share with us will be used for business purposes, such as communication with you, and handled in accordance with Wave’s Privacy Policy, Notice, Statements, and Additional Information. Wave collects, evaluates and retains candidate data for the legitimate interest of selecting a candidate for employment or contract purposes. Such data will be kept for no longer than necessary to carry out those purposes, unless you consent for your information to be retained up to an additional three (3) years for consideration for future opportunities at Wave. Any requests related to your Personal Information may be electronically submitted to Wave’s Data Protection Officer at wavelifesciences.com . If you choose to share your demographic background (such as race, gender or sex, national origin, age, disability or veterinary status) by completing the optional survey, your responses will be combined with the answers from other applicants in an aggregated and anonymized form which may be used for equal employment opportunity reporting, diversity and inclusion analysis, and to help us evaluate the effectiveness of our recruiting practices. The information you share will not be used for hiring decisions or provided to hiring managers or interviewers.

Requirements

Must-haves

8+ years Bio-Pharma industry in Aseptic Drug Product GMP environment with PPQ campaign experience required
Experience of authoring DP sections of CTA/IND/NDA/BLA submissions required
Experience in Oligonucleotide Manufacturing and Managing CMOs desirable
Experience with Pre-filled syringes and/or autoinjectors desirable
May include some or all of the following:
Plan and execute DP formulation development studies to select Phase appropriate DP Presentation
Initiate/Oversee PPQ activities at CMO ensuring commercial readiness for DP
Author DP sections of Regulatory submissions and provide timely responses to their questions
Ensure effective and efficient tech-transfer and GMP manufacturing of oligonucleotide adhering to strict quality standards at Wave and CMO sites
Function as interface/liaison between Process Development, Analytical, Quality, Regulatory and Supply Chain departments
Supports continuous improvement initiatives by identifying areas needing improvement and communicating strategies for improvement
Respond quickly and effectively to multiple and changing priorities, and to schedule work effectively to ensure that current and future needs are met
Technical review of batch records and process instructions internally and externally (CMOs)
Manage CMO relationships to ensure sufficient Drug Product supply of Wave Assets for clinical and commercial supply.
Experience in DP formulation development of liquid and lyophilized presentations including Drug delivery systems and combination products desirable
Strong scientific authoring experience and excellent communication skills required
Practical knowledge of cGMP regulations required
Ability to effectively manage time and prioritize tasks independently in a fast-paced environment
Proficient with MS Office Word, Excel, PowerPoint
Must be self-motivated, able to work independently, and have a proven ability to work in a team environment
Data Privacy and Your Information

Nice-to-haves

S. or Ph. D. degree in Pharmaceutical Sciences, Chemistry or Engineering is preferred OR equivalent work experience

Application prep

Use the role’s language and application details while tailoring your materials.

Platform: greenhouse
Effort: quick

Benefits

Benefits detected in the listing.

Dental

Vision

401k

Paid Time Off