What are the responsibilities and job description for the Sr. Scientist, Formulation and GMP Manufacturing position at Stoke Therapeutics?
About Stoke:
Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to addressing the underlying cause of severe diseases. The company is pursuing an entirely new approach to treating severe diseases. We are initially focused on diseases of the central nervous system and the eye, with an emphasis on haploinsufficiencies, which are diseases caused by a loss of about half of the normal protein levels. Rather than replace, repair or edit faulty genes, we aim to increase – or stoke – protein output from healthy genes to restore functional protein levels using our proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) platform. In all, Stoke has identified ~6500 genes with a TANGO signature, representing broad potential for our approach to help people with severe diseases.
We recently announced landmark data that support the potential for STK-001 to be the first disease-modifying medicine for Dravet syndrome, a severe and progressive genetic epilepsy that is characterized by frequent, prolonged and refractory seizures, beginning within the first year of life. The disease is classified as a developmental and epileptic encephalopathy due to the developmental delays and cognitive impairment associated with the disease.
Stoke is also advancing STK-002, a potential treatment for autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Currently there are no approved treatments for ADOA. Clinical studies of STK-002 are anticipated to start in 2024. The company is pursuing potential new medicines for three additional neurodevelopmental disorders, including Syngap1 and Rett syndrome, in collaboration with Acadia Pharmaceuticals.
Position Purpose:
The Sr. Scientist, Formulation and GMP Manufacturing , will be responsible for assisting in the development of oligonucleotide drug products and manufacturing process ensuring the timely and efficient delivery of investigational medicinal products. This position will report to the Senior Principal Scientist, Manufacturing.
Key Responsibilities:
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is a hybrid position with an office setting based in our Bedford, MA location.
Travel:
This position will require approximately 5-10% travel to CMO as required.
Culture & Values:
At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual’s needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.
Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging Committee (DIB) underscores the importance of DIB to who we are and what we do.
Benefits & Compensation:
At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible.
Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center:
https://www.stoketherapeutics.com/careers/
For more information, visit https://www.stoketherapeutics.com/ or follow the company on Twitter at @StokeTx.
All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.
Stoke participates in E-Verify.
Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to addressing the underlying cause of severe diseases. The company is pursuing an entirely new approach to treating severe diseases. We are initially focused on diseases of the central nervous system and the eye, with an emphasis on haploinsufficiencies, which are diseases caused by a loss of about half of the normal protein levels. Rather than replace, repair or edit faulty genes, we aim to increase – or stoke – protein output from healthy genes to restore functional protein levels using our proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) platform. In all, Stoke has identified ~6500 genes with a TANGO signature, representing broad potential for our approach to help people with severe diseases.
We recently announced landmark data that support the potential for STK-001 to be the first disease-modifying medicine for Dravet syndrome, a severe and progressive genetic epilepsy that is characterized by frequent, prolonged and refractory seizures, beginning within the first year of life. The disease is classified as a developmental and epileptic encephalopathy due to the developmental delays and cognitive impairment associated with the disease.
Stoke is also advancing STK-002, a potential treatment for autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Currently there are no approved treatments for ADOA. Clinical studies of STK-002 are anticipated to start in 2024. The company is pursuing potential new medicines for three additional neurodevelopmental disorders, including Syngap1 and Rett syndrome, in collaboration with Acadia Pharmaceuticals.
Position Purpose:
The Sr. Scientist, Formulation and GMP Manufacturing , will be responsible for assisting in the development of oligonucleotide drug products and manufacturing process ensuring the timely and efficient delivery of investigational medicinal products. This position will report to the Senior Principal Scientist, Manufacturing.
Key Responsibilities:
- Conduct hands-on work to develop oligonucleotide formulations in-house, perform testing, and apply Design of Experiments (DOE) where applicable to optimize and scale up processes from R&D to full-scale manufacturing at contract facilities.
- In-depth theoretical knowledge and hands-on experience with physicochemical and biophysical characterization methods and techniques including DSC, UV/VIS, CD, HPLC, LC-MS, particle counting and sizing, osmometer, viscometer and others.
- Demonstrated scientific track record in oligonucleotide drug product process development by industry experience and/or external scientific publications and patents.
- Strong background in applying a sound scientific approach to experiment design and data analysis/interpretation.
- Experience in authoring reports, methods, and demonstrated working knowledge on FDA, EMA ICH, and other regulatory guidance.
- Participate in the selection of manufacturing equipment, overseeing the process from prototype development to full-scale production, both in-house and at contract manufacturing organizations when necessary.
- Implement problem-solving techniques to identify, assess, and mitigate potential manufacturing issues.
- Author and review technical documents such as engineering studies, Mater Batch Record (MBR), Executed Batch Records (EBR), Filter Validation Protocols and other related process validation protocols and manufacturing plans.
- Develop and maintain strong relationships with external Contract Manufacturing Organization, and internal Process Engineering, Regulatory, and Quality Assurance teams to support process development and improvements.
- Proven teamwork, and collaboration skills with a demonstrated ability to interact with and influence diverse audiences.
- Familiarity with software tools but not limited to JMP, Master control, Veeva, Prism etc.
- PhD degree in Bio/Chemical Engineering, Pharmaceutical Sciences, Bio/Chemistry, or related scientific field or MSc with 4 years of industry experience or BSc with 6 years of industry experience.
- One or more years of experience in oligonucleotide or small molecule sterile drug product development is desired.
- Good understanding of biopharma/oligonucleotide drug product and process development.
- In-depth knowledge and hands-on experience with oligonucleotide delivery including but limited to intrathecal, ocular, intravenous delivery routes.
- Experience with analytical characterization techniques of oligonucleotide drug products (UV-Vis, CD, SLS/DLS, particle characterization, FTIR, IR, DSC, chromatography, etc.).
- Demonstrated ability to design, conduct, and analyze experiments.
- Strong organizational skills and the ability to manage multiple priorities in a matrix environment.
- Excellent written and verbal communication skills.
- Strong attention to detail.
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is a hybrid position with an office setting based in our Bedford, MA location.
Travel:
This position will require approximately 5-10% travel to CMO as required.
Culture & Values:
At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual’s needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.
Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging Committee (DIB) underscores the importance of DIB to who we are and what we do.
Benefits & Compensation:
At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible.
Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center:
https://www.stoketherapeutics.com/careers/
For more information, visit https://www.stoketherapeutics.com/ or follow the company on Twitter at @StokeTx.
All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.
Stoke participates in E-Verify.
