San Bruno Job Description Sample
Seasonal Associate-Tanforan Park
Product Manager, Customer Experience
FT Freight Associate
CNA Caregiver (3415Pp - SO. SAN Francisco)
Senior Equipment Engineer
CMC Project Manager
Encoded Therapeutics is a therapeutics company combining the precision of gene regulation with the versatility of gene therapies to create breakthrough treatments for individuals living with severe genetic diseases.
We are recruiting a CMC Project Manager to join our team to support planning, budgeting, tracking and communication across functional groups for Encoded’s AAV gene therapy programs. This is a unique opportunity to work at the intersection of genomics and therapeutics and participate in the development of a diverse therapeutic pipeline driven by a transformative core technology. The successful candidate will work closely with both internal groups and the Company’s designated Contract Manufacturing and Contract Research Organizations (“CMO/CRO”). This position requires a highly motivated self-starter with a strong PM and technical background who can assimilate new information quickly. This individual will report to the Program Management Office and will utilize established PM tools and help further identify tools and processes needed to support the successful development and delivery of Encoded research and development programs.
- Partner with the Program Lead to identify risks, mitigations and ensure timely problem solving and communication.
- Support cross-functional teams in the development of integrated timelines, planning and executing on development of AAV gene therapy programs (IND through Phase I/II/III and launch).
- Partner with PM organization, establish and/or refine standard project management processes, systems, and tools.
- Drive execution of all stages of a project with internal teams and external CMOs/CROs in partnership with the Program Lead.
- Facilitate communication within the project team to identify risks, mitigations and communicate as appropriate.
- Partner with Program Lead to ensure cross-functional teams are properly prepared for internal meetings, communications to management and engagement with external partners.
- Utilize formal communication protocols and tools including dashboards, reports, weekly/monthly updates, and any other specific information as needed for internal use and for CMO/CRO engagement to help achieve company and operational goals.
- Drive risk management including conducting cross-functional or functional team level program risk assessments and scenario planning to understand impact and sensitivity of issues and plans.
- Partner with Program Lead to proactively drive the development of contingency and/or risk mitigation plans.
- Science or Engineering Bachelors/Masters or Ph.D. a plus.
- Minimum of 7+ years hands-on client-facing project management experience and training in biotechnology/pharmaceutical industries.
- 5+ years of AAV and/or LVV gene therapy experience is preferred.
- Experience in CMC tech transfers, manufacturing, quality systems, CMO management pre-clinical & clinical development and experience developing under regulatory requirements.
- Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment.
- Must have excellent communication, team management, and conflict resolution skills.
- Strong client-facing interpersonal skills coupled with a concern for impact. Rational Persuasion.
- Strong time management and organizational skills. Ability to multi-task in a fast-paced environment. Attention to detail and concern for standards.
- Excellent written and oral communication skills both internal and external.
- Identify and mitigate potential project risks with the team and develop mitigation strategies. Communicate program status, progress, risks including elevation of issues as needed, to key internal and external stakeholders. Ability to resolve conflict within project teams and know when to escalate if needed.
- Proficient utilizing MS Office Suite, specifically MS Project (or Smart Sheets), PowerPoint, etc.
- Up to 20% Travel may be required.
- PMP Certification preferred.
- Comprehensive benefits package, including competitive employer premium contributions
- Meaningful stock option grants
- PTO, sick time and holiday pay
- Generous Parental Leave program
- Pre-tax medical and dependent care programs
- LTD, Life, and AD&D
- Professional development opportunities
- Team-building events
- Fully stocked kitchen
Encoded Therapeutics, Inc. is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.
If you need assistance or an accommodation due to a disability, you may call us at +1 650-491-0272.
Associate/Director, Process Development
The complex ecosystem of bacteria that comprise our gut microbiome are inextricably tied to the overall quality of human health. Federation Bio is a new start-up company poised to leverage the power of active microbial communities to address high unmet medical needs. Our approach lies at the intersection of microbiology, chemistry, and genomics and uniquely enables us to harness the power of the microbiome and define the potential of this new therapeutic modality.
Federation was founded by two leading academics in the microbiome field (Stanford Professors Michael Fischbach and Dylan Dodd) as well as Venrock, one of the leading venture capital funds in the United States.
Description of Role
We are currently seeking an experienced, creative, and highly motivated Process Developer to build in-house manufacturing capabilities including but not limited to: innovative systems, building a team, and identifying and removing barriers to efficient production of complex communities of anaerobic microbes. This person would be responsible for the overall bioprocess development and implementation strategy in collaboration with the research team including a role in influencing research direction and strategies for strain selection. Additional responsibilities include hands on process development around the early research grade and GMP material at Federation Bio. A core focus is the ability to rapidly develop processes to culture, purify, and combine diverse anaerobic bacteria for therapeutic use. This process developer will play a critical role in the development of novel microbiome therapeutics to support the development of exciting new therapies across a variety of diseases.
Core responsibilities and opportunities are:
- Design and development of internal scalable fermentation processes for a variety of anaerobic microbial strains
- Manufacturing master cell banks, combined communities, and final drug product in an early phase GMP environment
- Setting appropriate release specifications for the components of the drug substance as well as the final drug product
- Identifying and qualifying analytical methods in order to ensure the delivery of quality products for dosing
- Authoring CMC sections of briefing books and/or other submissions (e.g. IND) for regulatory authorities
- Preparing media, buffers, single-use components for GMP use
- Operating and maintaining small-scale process equipment
- Ordering and inventorying raw materials
- Coordinating 3rd party contractors and vendors as needed
- Collaborate with experimental biologists to design well-controlled experiments, develop best practices for strain growth and characterization
- Communicate clearly, work independently, collaborate heavily, think critically
- Extensive experience with bioprocess development of anaerobic microbes or other types of cultures
- Experience in media optimization and developing scalable downstream production processes
- Authorship of early phase CMC regulatory submissions for products containing live bacterial products (LBP)
- Familiarity with LBP FDA regulations and GMP standards
- Advanced and applied mathematics for process modeling, network analysis, metabolomics
- Proven track record for rapid development, IP innovation, and scale-up for early-phase biologics
- BS preferably in chemical or bioengineering, mechanical engineering, or related technical discipline
- At least 7 years of hands-on experience in early process development
- Direct experience with cell banking, cell culture, fermentation, lyophilization, and/or capsule filling is desired.
Our ideal teammate is creative, flexible, rigorous, and innovative, with a well-developed ability to operate effectively within a multidisciplinary team in a fast-paced environment.
Competitive salary and benefits
Financial Services Manager (19917848)
Fy20 Intern Conversion: Data Scientist
Talent Sourcer - Corporate Functions
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