Director Formulation Development Jobs in Somerville, MA

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, as well as a preclinical program in 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:
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:

• M.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 External Disclosure Statement
The annual base salary range for this position is $163,000 - $221,000
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.
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.