Scientist, CMC Process Sciences
1 month ago
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:
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.
-
Senior Manager, Vaccines Development CMC
3 weeks ago
Waltham, Massachusetts, United States GlaxoSmithKline Full timeReady to help shape the future of healthcare? Your talent can bring our science to lifeAs a , we empower you to be yourself, share ideas and work collaboratively Senior Manager Vaccines Development CMC Job purpose: As a Senior Manager Vaccines Development CMC, you will lead CMC regulatory activities for investigational, late development and/or early...
-
Project Manager, CMC Regulatory Affairs
3 weeks ago
Waltham, Massachusetts, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - Upper Providence, GSK House, UK - Hertfordshire - Ware, USA - Maryland - Rockville, USA - Massachusetts - Waltham, Zug HousePosted Date: May At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering...
-
Project Manager, CMC Regulatory Affairs
1 month ago
Waltham, Massachusetts, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - Upper Providence, GSK House, UK - Hertfordshire - Ware, USA - Maryland - Rockville, USA - Massachusetts - Waltham, Zug HousePosted Date: May At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering...
-
AD/Director, Regulatory Affairs CMC
1 week ago
Waltham, Massachusetts, United States Zenas BioPharma Full timeZenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. With clinical development and operations globally, Zenas is advancing a deep and balanced global portfolio of potential first- and best-in-class autoimmune therapeutics in areas...
-
Waltham, Massachusetts, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - Upper Providence, UK - London - New Oxford Street, USA - Massachusetts - Waltham, Ware RDPosted Date: Jun Does leading and delivering Chemistry and Manufacturing Controls regulatory strategy interest you? If so, this role may be for you We're seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs...
-
Director, CMC Bioconjugation
3 weeks ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany 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....
-
Director, CMC Bioconjugation
1 month ago
Waltham, Massachusetts, United States Dyne Therapeutics Full timeCompany 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....
-
Mad Science Instructor
1 week ago
Waltham, Massachusetts, United States Mad Science of Southern MA & RI Full timeJob DescriptionJob DescriptionHere is the part-time job with very flexible hours paying $17 to $30 per hour that you have been looking for to have fun teaching childrenAt Mad Science, we are having a blast We pay you to have fun Build and fly rockets, demonstrate lasers, explore the states of matter using dry ice, and help children create slime and other...
-
Waltham, Massachusetts, United States The Steely Group Full timeOur client is looking for an outstanding candidate for a critical position to lead their Manufacturing Science and Technology (MSAT) Organization in support of their growing client portfolio for genomic medicines. This role is responsible for leading and growing a team responsible for end-to-end technical support of GMP manufacturing of autologous/allogenic...
-
Waltham, Massachusetts, United States AstraZeneca Full timeJob DescriptionScientist Bioscience Immunology, Early Respiratory And ImmunologyAre you passionate about science and eager to apply your expertise in a company that follows the science and turns ideas into life-changing medicines? If so, AstraZeneca might be the one for you We are seeking a highly motivated research associate or scientist with hands-on...
-
Associate Scientist
3 weeks ago
Waltham, Massachusetts, United States Cambrex Full timeCompany Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a...
-
Associate Scientist
2 months ago
Waltham, Massachusetts, United States Cambrex Full timeCompany Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a...
-
Senior Scientist, Bioinformatics
3 weeks ago
Waltham, Massachusetts, United States CSL Seqirus Full timeWe have an exciting opportunity available for Senior Scientist, Bioinformatics & Data science, to join our Biopharmaceutical Product Development (BPD) department to shape the data analytics infrastructure, lead RNA–centric bioinformatics pipeline development and transform next–generation sequencing (NGS) data to therapeutics discovery.As the first...
-
In Vivo Sr Scientist, Oncology Research
1 week ago
Waltham, Massachusetts, United States AstraZeneca PLC Full timeIn Vivo Sr Scientist, Oncology ResearchAre you ready to make a difference in the world of oncology research & development? At AstraZeneca, we follow the science and turn ideas into life-changing medicines. If you have a passion for in vivo & in vitro experiments, we might be the perfect fit for you Join us and work on the next generation new drug modalities....
-
In vivo Senior Scientist Oncology Team
1 week ago
Waltham, Massachusetts, United States AstraZeneca Full timeJob DescriptionIn vivo Senior Scientist Oncology Team (Hematology)Are you ready to redefine cancer and transform the lives of patients? At AstraZeneca Oncology R&D, we are pioneering a new approach to oncology. We are seeking an In vivo Senior Scientist to join our dynamic and collaborative team in our innovative Bio hub facility in Waltham, MA Your primary...
-
Process Engineer
1 week ago
Waltham, Massachusetts, United States LASE Innovation Inc. Full timeWe are seeking a highly motivated individual with a successful track record to join LASE Innovation as a Process Engineer. LASE Innovation is a life science platform startup company that is ushering in a new era of ultrahigh dimensional single-cell analysis to solve complex biological problems and diseases by providing access to high-dimensional...
-
Waltham, Massachusetts, United States GlaxoSmithKline Full timeSite Name: UK - London - Brentford, Belgium-Wavre, Italy - Siena, Netherlands - Amsterdam, USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: May We're excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we're building an...
-
Waltham, Massachusetts, United States GlaxoSmithKline Full timeSite Name: UK - London - Brentford, Belgium-Wavre, Italy - Siena, Netherlands - Amsterdam, USA - Maryland - Rockville, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: May We're excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we're building an...
-
Waltham, Massachusetts, United States AstraZeneca PLC Full timeAre you enthusiastic about how Data Science can revolutionize clinical trials for new products?AstraZeneca is a company dedicated to leveraging scientific breakthroughs to develop life-changing medications.With innovative technologies, we are enhancing our ability to capture and utilize data effectively, leading to a deeper understanding of diseases,...
-
Waltham, Massachusetts, United States AstraZeneca Full timeJob DescriptionAre you a seasoned Early Clinical Scientist with experience in supporting Phase 1-2 studies? Do you have a keen interest in working across a variety of platforms such as IO, Antibody Drug Conjugates, Cell Therapy, Tumor Drivers and Resistance, Epigenetics and DNA Damage Response? If so, AstraZeneca, home to one of the most promising Oncology...
