- Oligonucleotide and drug substance process development, tech transfer, scale-up, and characterization
- Lead internal CMC oligonucleotide and oligonucleotide conjugate process development activities including hands-on contribution in the laboratory
- Work with CDMOs to manage external development, optimization, and tech transfer of new programs in a stage appropriate manner to ensure key milestones and products are delivered on schedule
- Partner with Research to support early-stage oligonucleotide and bioconjugate development activities
- Represent CMC and Process Sciences as a subject matter expert in internal cross-functional teams
- Contribute to preparation and review of CMC regulatory documentation for biologic INDs and BLAs in support of relevant interactions with health authorities
- Establish clear expectations and priorities, set objectives, and effectively apply resources to deliver on program goals
Education and Skills Requirements: - A degree in biology, biochemistry, chemistry, or similar related life science or engineering field is required
- A minimum of 3-5 years in biopharmaceutical CMC management and/or Research & Development preferably in a clinical-stage biotechnology company is required
- Oligonucleotide development, process scale-up, and tech transfer experience is required
- Hands-on experience working with single strand antisense (ASO), small interfering (siRNA), or morpholino (PMO) oligonucleotides is required
- A deep understanding of oligonucleotide conjugate, antibody drug conjugate (ADC), or small molecule conjugate development
- Expertise in oversight of external contract development and manufacturing (CDMO) partners
- A strong understanding of oligonucleotide, biologic, and small molecule manufacturing
- Familiarity with analytical development, quality control, quality assurance, and regulatory functions
- Experience with analytical characterization techniques HPLC/UPLC, IEX, SEC, SDS-PAGE, CE-SDS, ELISA, and UV/vis
- Excellent interpersonal, organizational, negotiation, and communication skills; a team member than can work collaboratively with colleagues across functions
- Self-directed individual who is able to work effectively with limited direction in a complex, fast-paced environment
- Ability to challenge current processes, practices, and strategy to uncover alternative approaches, solutions, or methods
#LI-Onsite
The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.
This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned. All Employees are expected to adhere to all company policies and act as a role model for company values.
Dyne Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. -
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Scientist, CMC Process Sciences - Waltham, United States - Dyne Therapeutics
Description
Company Overview:Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCETM platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue. Dyne has a broad pipeline for serious muscle diseases, including clinical programs for myotonic dystrophy type 1 (DM1) and Duchenne muscular dystrophy (DMD), and a preclinical program for facioscapulohumeral muscular dystrophy (FSHD).
Role Summary:
The position is responsible for process development, technology transfer, and management of external CDMO activities to ensure development of robust and reliable GMP manufacturing processes for oligonucleotides and oligonucleotide conjugates. This person will represent CMC Process Sciences as a technical leader to both internal and external stakeholders. The candidate will be a subject matter expert in the development of oligonucleotides and oligonucleotide conjugates. This role will support development of Dyne's platform programs from pre-clinical through process characterization and BLA. This includes hands on contributions in the lab to process establishment, process development, and process characterization. This person will also have oversight of CDMO technology transfer and process development operations.
This position works closely with key stakeholders including Platform Research, External Manufacturing, Clinical Operations, Regulatory Affairs, and Project Management to define and build the capabilities required to effectively develop and manage Dyne's complex clinical supply chain supporting launch and commercialization efforts.
The role is based in Waltham, MA without the possibility of being a remote. Applicants must be able to relocate to the area.
Primary Responsibilities Include:
