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CareersSenior Director, CMC
Senior Director, CMC
Azitra Inc. is an emerging biotechnology company that leverages its extensive knowledge of proteomics, genetic engineering and the skin microbiome to discover and develop novel products for the treatment of skin conditions and diseases. The company is looking to hire a Senior Director, CMC. This position will lead the development and execution of the CMC strategy. Reporting to the Chief Scientific Officer, this individual will provide project management and CMC experience to ensure CMC activities are executed in alignment with the clinical stage programs at Azitra Inc. This individual will work with cross-functional stakeholders in Clinical Operations and R&D to achieve CMC development and manufacturing milestones in accordance with clinical program timelines.
Duties and responsibilities
- Establish, manage and lead the CMC development programs for drug substances and drug products from pre-clinical through commercial development.
- Lead manufacturing strategy including selection and contract negotiation, ongoing troubleshooting, data analysis and interpretation.
- Work across functional groups in identifying issues that may delay timelines, providing solutions to difficult technical/functional issues associated with specific projects, as well as support the resolution of issues that arise.
- Maintaining program related CMC specific documentation, including, but not limited to, program plans, timelines, and budget.
- Support, prepare, and review applicable CMC portions of regulatory filings to regulatory authorities including FDA and other national authorities to support the conduct of clinical trials and submission of marketing applications.
- Coordinate internal program timelines and priorities with Contract Manufacturing Organizations.
- Proactively identify knowledge gaps and risks, and work with the teams and team leaders to develop mitigation plans.
- Facilitating internal CMC decision-making processes and preparing regular updates for senior management and Program Leaders.
- Strong knowledge of GMP regulations as well as familiarity with regulatory requirements surrounding import and distributions.
- PhD preferred in a relevant area of study, with a minimum of 10 years of relevant experience in pharmaceutical GMP development and process chemistry.
- Strong foundation in chemistry, materials science, pharmaceutical sciences or chemical engineering required.
- Experience preparing successful CMC sections of regulatory submissions
- Ability to effectively lead and participate on multi-disciplinary teams.
- Strong interpersonal skills and excellent oral and written communication skills
- Ability to provide hands-on problem-solving skills and strong critical thinking.
- Proven experience as a direct manager of people and/or external teams, and as a leader for milestone and budget-driven projects.
- The desire to work in a fast-paced, timeline-driven environment, and ability to manage outsourced projects with external vendors.
- Outstanding written and verbal communication skills, with the ability to convey CMC strategies and results to a varied audience.
- Strong working knowledge of cGMP regulations and ICH and CDER guidelines applicable to the development and production of API and drug product.
Subject Line: Senior Director, CMC
Azitra is seeking an organized and motivated Laboratory Manager to join our team. This person will also have some minor facilities responsibilities and will ensure the smooth operation of our fast-paced and highly effective Microbiome Laboratory in Branford, CT. The ideal candidate will be experienced in the efficient operation of biological research laboratories, be meticulous, able to multi-task and have excellent communication skills.
Laboratory Operations: Manage ordering and stock of laboratory supplies for both Connecticut and Canadian facilities. Direct the conduct of standard laboratory upkeep and maintenance to ensure highly organization laboratory workspace. Ensure proper functioning and care of laboratory equipment.
Facility Operations: Develop and maintain standards for planned preventative maintenance and office upkeep to assure optimal functioning of all building systems. Work with building owner on all maintenance issues. Anticipating facilities needs and actively addressing issues before they are occurred is key.
Standard operating procedures: Generate and maintain standard operating procedures (SOPs) for laboratory and research tasks. Monitor compliance to facility SOPs..
Communication and reporting: Keep detailed records of all activities and provide weekly updates to the Chief Operating Officer.
Job duties to include (but not limited to):
- Assume accountability for successful operations of a fast-paced and growing laboratory. This will include building out and managing a laboratory inventory plan, purchasing, implementing steps to improve efficiency, troubleshooting issues, and increasing the effectiveness of the lab over time.
- Assume responsibility for all instrument maintenance and user trainings, including daily upkeep, establishing and managing maintenance contracts, tracking and coordinating maintenance, calibrations, and scheduling repairs.
- Organize and manage lab space and resources, including organizing and allocating freezer/ refrigerator/ liquid nitrogen space, organizing and stocking consumables/reagents, and tracking inventory. Coordinate laboratory receiving to ensure items are brought to the correct people and are stored at the correct temperature.
- Generate and maintain standard operating procedures (SOPs) for laboratory and research tasks. Ensure compliance to SOPs in conduct of research.
- Training personnel on laboratory operations, procedures, and conduct.
- Manage shipping and receiving, including the logistics for timely shipping and receiving of sensitive samples. Safely and securely package materials for delivery. Draft customs invoices and shipping declarations in accordance with international standards, and coordinate shipping with various couriers.
- Manage the incoming supply chain. Order lab supplies according to inventory level thresholds and custom order requests for needs and projects. Track supply inventory and address or modify needs in a timely manner.
- Oversee all aspects of safety and compliance, including tracking/managing of chemicals and hazardous materials, establishing and facilitating PPE policy, and coordinating laboratory employee safety trainings.
- Lead Environmental Health and Safety efforts with the Company serving as EHS Officer maintaining training records and compliance with biosafety and chemical safety protocols.
- Manage biohazardous and chemical waste storage and remove,
- Manage office and building operations, procedures and maintenance.
- Oversee janitorial and maintenance services and coordinate with Building Owner.
- Maintain operating status and planned/unplanned outages for all systems, facilities, utilities to provide “up time” for the site.
- Bachelor’s Degree, ideally with at least two years of experience working in an industry laboratory setting.
- SOP development, record keeping skills
- Excellent computer skills including proficiency in Microsoft Word, Excel, and PowerPoint.
- Experience using inventory tracking software (PeopleSoft, BoxStorm, LabCloud, etc.) strongly preferred.
- Familiarity with a wide range of laboratory consumables and equipment used in the biological sciences.
- Meticulous organizational skills and attention to detail. Must be able to handle multiple tasks/priorities under specific time constraints.
- Must possess a high level of initiative and be able to work with little supervision.
- Outstanding verbal and written communication skills.
Job Type: Full-time
Subject Line: Laboratory Manager
Azitra is an emerging biotechnology company that leverages its extensive knowledge of proteomics, genetic engineering and the skin microbiome to discover and develop novel products for the treatment of skin conditions and diseases. Reporting to the Controller you will be responsible for the effective day to day management of the accounts payable, accounts receivable and payroll functions as well as maintenance of all filing and electronic records.
- Operate consistent with and monitor compliance of the team with accounting Policies and Procedures
- Preparation of voucher packages and entry into the financial system
- Preparation of the monthly credit card and entry into the accounting system
- The review of all expense reports and entry into the financial system
- Preparation of weekly check runs and wire transfers
- Maintenance of the Positive Pay System
- Preparation of deposits and entry into the financial system
- The review and maintenance of all employee timecards
- Preparation of the bi-monthly US and Canadian payroll runs and entry into the financial system
- Maintenance of financial information for grant reporting purposes
- Preparation of grant reports
- Preparation of journal entries, analyses, and account reconciliations and assisting with monthly close process
- Assist in filing Canadian GST and QST Quarterly Sales Tax Returns
- Assist in filing US and Canadian tax returns
- Assist with the preparation of the US R&D Credits and Canadian SRED Credits
- Assist with the preparation of W2s and 1099s
- Assist in preparation and review of financial statements
- Assist with audits
- Maintenance of filing and electronic records
- Respond to all information requests
- Resolution of all payment discrepancies and disputes
- Development and maintenance of positive relationships with internal team
- Perform other tasks as directed by Controller
Skills & Abilities
- Bachelor’s Degree in Accounting
- 1-3+ years proven experience
- Working knowledge of Quickbooks and Excel software required
- Experience with grant accounting
- Foreign currency translation experience
- Detail oriented with a focus on accuracy
- Ability to multi-task and work in a high volume, fast paced environment
- Able to successfully work independently and as part of a team
- Strong interpersonal and verbal/written communication skills as well as the ability to maintain professionalism under pressure
- Strong problem resolution skills
- Effective organizational skills
- Self -motivated
Subject Line: Staff Accountant
Associate Research Scientist/Research Scientist – Molecular Microbiologist
Azitra Inc. is an emerging biotechnology company that leverages its extensive knowledge of proteomics, genetic engineering and the skin microbiome to discover and develop novel products for the treatment of skin conditions and diseases. The company is looking to hire a Molecular Microbiologist at the Associate Research Scientist or Research Scientist level.
As an Associate Research Scientist/Research Scientist you will;
- Independently design and engineer Gram-negative and Gram-positive bacteria to optimally express specific phenotypes and recombinant proteins.
- Analyze data from genomic sequencing of bacterial isolates for the identification of specific genes and biosynthetic gene clusters affecting strain properties.
- Conduct experiments to characterize the in vitro and in vivo properties of constructed bacterial strains.
- Propose and prioritize next steps for strain improvement, and systematically trouble-shoot technical hurdles.
- As appropriate, identify, pursue, and implement new technologies to support and expand internal capabilities.
- Constructively contribute new ideas, suggestions, insights at project meetings, as well as ad hoc.
- Support internal and external collaborations.
- Record and present data in well-organized written and oral formats.
- Write study reports and draft manuscripts.
- Work effectively in a highly collaborative team environment.
- Attend and present at internal and external meetings/conferences as required.
You background will likely include:
- A background in molecular microbiology, experience in prokaryotic recombinant gene expression, bacterial physiology, genetics and strain construction.
- Experience with genome analyses, bioinformatic tools, and use of relevant databases.
- Familiarity with handling BSL-2 bacteria, mammalian cell culture, and sterile technique.
- Experience in the development and performance of biochemical and mammalian/bacterial cell-based assays.
- The ability to design/troubleshoot/ validate assays, and critically analyze assay data.
- Excellent technical and computer skills; familiarity with current molecular techniques and software, including the ability to design/construct. plasmids, genetically manipulate bacterial strains, and analyze sequence data for cloning purposes. Routine experience with Western blots, ELISAs, PCR, qPCR.
- Ability to work with database-related software to manage and capture study data.
- PhD , MS plus 2 years experience, or BS plus 5 or more years experience; degree in biology, microbiology, molecular biology, genetics, or biotechnology.
- Prior experience in recombinant gene expression in bacteria, proficiency in cloning/plasmid construction, and bacterial strain construction are absolutely required. Knowledge of bacterial physiology, genetics and experience with Gram-positive bacteria are highly desired. Experience working with skin commensal bacteria a plus.
Subject Line: Molecular Microbiologist