Senior Director, Quality Control Analytical Sciences
Abata TherapeuticsSalary not specified
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries
Requirements
- Experienced and highly motivated in analytical development and quality control for small molecule drug discovery and development programs
- Ability to act as subject matter expert (SME) and functional lead for CMC development and manufacturing activities
- Expertise in collaborating with and managing consultants and CDMO partners
- Knowledge of industry standards, regulatory expectations, and Health Authority guidance
Responsibilities
- Act as an SME for Analytical Development in the support of drug substance and drug product development, including process chemistry, form and formulation development, and GMP manufacture
- Contribute to the CMC control strategies, including development, review, and justification of specifications for raw materials, intermediates, drug substance, and drug product in alignment with industry standards and regulatory expectations
- Develop analytical test methods and manage method validation and transfer as necessary to support CDMO GMP manufacturing, release, and stability of drug substance and drug product
- Author and review analytical methods, protocols, reports, batch records, change controls, corrective and preventative actions, deviations, and investigation, including OOS and OOT events
- Write and review CMC sections of regulatory documents and submissions (IMPD, IB, IND, NDA, etc.) and the supporting technical documents, and remain current on Health Authority guidance and expectations
- Contribute to the development of CMC strategies to meet program and project development targets, ensure timely and efficient delivery of high-quality products, and facilitate regulatory approvals
- Support development
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the reporting structure for the Associate Director/Director of Analytical Development role?
The role reports to the Vice President, CMC.
Is this position remote or on-site?
This information is not specified in the job description.
What are the main responsibilities of this role?
The role involves acting as an SME for Analytical Development supporting drug substance and drug product development, including process chemistry, form and formulation development, and GMP manufacture, while contributing to CMC control strategy.
What is the company culture like at Septerna?
Septerna embraces diversity of thought, expertise, and background through collaboration, encourages bringing your real self to work, and cultivates a team-oriented environment focused on learning, innovation, and developing meaningful therapeutics.
What makes a strong candidate for this position?
Septerna seeks an experienced and highly motivated individual to serve as the SME and functional lead in analytical development, capable of managing consultants and CDMO partners in a fast-paced environment to advance small molecule programs.
Superna
Data protection solutions for Dell EMC Isilon
About Superna
Superna Eyeglass provides data protection solutions specifically designed for Dell EMC Isilon storage systems. Their products include tools for data replication, disaster recovery, and compliance auditing, which help enterprise clients manage their data securely and efficiently. The software operates on a subscription model, allowing clients to receive regular updates and technical support. What sets Superna Eyeglass apart from competitors is its focus on the unique needs of Dell EMC Isilon users, enabling them to offer specialized services in the data protection market. The company's goal is to ensure that clients can maintain secure operations while meeting compliance requirements.
Ottawa, CanadaHeadquarters
2002Year Founded
BUYOUTCompany Stage
Data & Analytics, Enterprise SoftwareIndustries
51-200Employees
Risks
Emerging startups offer innovative solutions at lower costs, threatening market share.
Cloud-native solutions may outpace Superna's current offerings, reducing attractiveness.
Vulnerability in Dell EMC Isilon systems could impact client trust if not addressed.
Differentiation
Superna Eyeglass specializes in Dell EMC Isilon storage systems, carving a niche market.
The company offers a subscription model, ensuring ongoing software updates and support.
Superna provides tailored solutions for data replication, disaster recovery, and compliance auditing.
Upsides
Rising demand for hybrid cloud solutions boosts Superna's market potential.
New data privacy regulations increase demand for compliance auditing tools.
Ransomware threats drive demand for robust disaster recovery solutions.
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