Graybug Vision is a clinical-stage pharmaceutical company focused on developing the next generation of products for the treatment of chronic vision-threatening diseases of the retina and optic nerve.

We are currently seeking qualified candidates for the following position(s):

Sr. Analytical Chemist / Associate Director of Analytical Chemistry

Job Title: Senior Analytical Chemist/Associate Director of Analytical Chemistry
Department: Research
Location:  Baltimore, MD
Reports to: Senior Director of Research
Type: Regular
Work Schedule: Full-Time
FLSA Status: Exempt

Job Summary

The Senior Analytical Chemist/Associate Director of Analytical Chemistry will play a key role in the development of lead products and the advancement of R&D programs. He/she will be responsible for developing and validating analytical methods for small-molecule APIs and formulations and transferring established methods to CROs/CMOs. Responsibilities also include collaborating with other research team members to screen and identify lead compounds and formulations. Other duties of the job include working closely and collaboratively with business partners, advisors and consultants, company employees, external vendors and suppliers to provide guidance and support for other R&D and regulatory activities when necessary.

Duties and Responsibilities – Essential Functions

• Lead all internal analytical method development and validation activities, including the development and implementation of new assay methods, enhancement of existing methods
• Work collaboratively with company employees, business partners, raw material suppliers and preclinical vendors to develop and validate analytical methods to support product development.
• Write relevant sections of regulatory submissions including IND.
• Provide scientific/technical guidance for other R&D activities as required.

Job Specification

• Ph.D. or M.S. in chemistry, biochemistry, pharmacology or related fields
• A minimum of 5 years of industrial experience in pharmaceutical development.
• Extensive knowledge and hands-on experience in essential analytical characterization tools, particularly LC and LC-MS analysis for small-molecule compounds.
• Familiarity with FDA regulations and guidance, and experienced in designing and conducting appropriate assay development and validation studies to support product development and regulatory submissions including IND.
• Strong verbal and written communication skills and interpersonal skills.

Desired Key Competencies

• Ability to achieve in a dynamic, fast-paced, multi-tasking environment of a milestone-driven, rapidly changing research environment.
• Possess a high degree of personal responsibility.
• An enjoyment of working collaboratively in a team environment with scientists of different backgrounds and experience levels.
• Ability to prioritize and re-prioritize activities as needed to accomplish unanticipated requests or initiate new projects requiring immediate attention.
• Good planning, organization, and execution skills.
• Demonstrates the highest ethical standards and trustworthiness.

Resumes can be sent directly to: HR@graybug.com

VP/SVP Manufacturing

Job Title: VP/SVP Manufacturing
Department:  Development
Location:  Redwood City, CA
Reports to: CEO
Type:  Regular
Work Schedule:  Full-Time
FLSA Status: Exempt

Job Summary

The Vice President/Senior Vice President will be responsible for all aspects of Manufacturing for Graybug Vision products.  He/she will work with Research to provide scientific oversight into the process design, scale-up and non-GMP lot processes. He/she will manage the process, analytical, and formulation development work at the CMO. Responsibilities will also include management of technology transfer from Research to CMOs and between CMOs as appropriate. In addition, he/she will manage the relationship with the CMOs to ensure timely production of high quality GMP materials for clinical trials and eventually commercial production. It is expected that as head of Manufacturing, he/she will work closely with other development functions at Graybug Vision and external consultants and collaborators to assure the processes are robust and meet the business and regulatory needs of Graybug Vision.

Duties and Responsibilities — Essential Functions

  • Proposes, designs and reviews process, analytical, and formulation development work conducted at drug substance and drug product CMO
  • Manages drug substance CMO on process development and analytical development
  • Manages drug product CMO on process development and analytical development work in collaboration with Research
  • Works with Research to transfer the non-GMP drug product process into the GMP drug product environment at the CMO
  • Works with Research and Quality to ensure that analytical methods are properly designed and implemented enabling transfer to QC function at CMO
  • Facilitates transfer of manufacturing processes from Research to CMOs for Graybug Vision’s products
  • Coordinates with Regulatory Affairs to supply process, analytical, and formulation development data in regulatory submissions
  • Coordinates GLP toxicology supply from CMO to CRO as required by Preclinical Development
  • Develops and manages supply chain for clinical and commercial supply
  • Manages the GMP production of drug substance (as required) and drug product at CMOs
  • Identifies and manages drug substance CMOs as needed
  • Other duties and responsibilities as assigned
  • Position requires travel to CMOs

Job Specification

  • BS, MS or PhD in chemistry or chemical engineering
  • With BS or MS a minimum of 20 yrs experience or with a PhD a minimum of 15 yrs experience in Manufacturing with more than 5 years as a senior manager or above (Sr. Director or Director; VP or SVP role) in a Manufacturing function at a biotechnology or pharmaceutical company
  • Experience with building, implementing, and managing small molecule and aseptic manufacturing processes is required
  • Hands on experience in designing and implementing experiments to evaluate processes, analytical methods, and formulations for small molecule therapeutics and drug delivery systems
  • Experience with process transfer to CMOs and management of CMOs
  • Working knowledge of current requirements for cGMP is required
  • Understanding of guidelines required by FDA, EMA and other regulatory bodies including experience with IND, CTX, NDA, BLA, and MAA submissions
  • Experience in writing appropriate sections of IND and/or IMPD is required
  • Commercial production experience and direct involvement in pre-approval inspection(s) is desirable
  • Effective working with a diverse team of consultants and external collaborators
  • Forward-thinking and creative with high ethical standards
  • Team player with leadership skills
  • Strategic thinker with sound technical skills, analytical ability, good judgment and strong operational focus
  • Well organized and self-directed
  • Strong interpersonal skills with an ability to communicate to people at all levels of an organization

Resumes can be sent directly to:  HR@graybug.com

VP/SVP Preclinical Development

Job Title: VP/SVP Preclinical Development
Department: Preclinical
Location:  Redwood City, CA
Reports to: CEO
Type: Regular
Work Schedule: Full-Time
FLSA Status: Exempt

Job Summary

The VP/SVP Preclinical Development will be responsible for leading, planning, coordinating, managing and reporting on preclinical activities at GrayBug Vision. He/she will manage and lead the preclinical research and development activities to enable validation of lead compounds for development as well as nonclinical pharmacology and toxicology studies to support regulatory submissions. Initially, VP/SVP will be involved in the day-to-day management of outsourced preclinical studies. He/she will initially manage external consultants with expertise in toxicology and pharmacology, and will build a small team to support the ongoing R&D activities of the Company. The candidate should have a strong familiarity with ophthalmic drug discovery and development, including standard preclinical efficacy, PK, and safety models. He or she will also be responsible for ensuring that all components are in place for the successful completion of these studies. Following completion of preclinical studies, VP/SVP will support the analysis, interpretation, and communication of data for internal and external audiences. This position requires someone with initiative, effective communication skills, attention to details, and the ability to work as part of a multi-disciplinary team. As a member of the Executive Team, he/she will assist the CEO in setting the corporate strategy for R&D and will work closely with other key functions in the Company. In particular, the role requires collaboration with the Research, Clinical Development, Manufacturing, and Finance Teams.

Duties and Responsibilities — Essential Functions

  • Plans and designs in vivo and ex vivo experiments in preclinical models relevant to ophthalmic drug discovery and development
  • Develops strategy for lead candidate selection through in vivo screening and target product profile development in collaboration with Research and Clinical Development
  • Writes up Requests for Proposals to CROs; evaluates cost proposal and CRO competencies for carrying out preclinical
  • Develops and reviews study protocols and manages outsources studies
  • Organizes, analyzes, and reports data from preclinical studies for regulatory, scientific, and patent purposes
  • Makes decisions on work programs and monitors project and program costs
  • Monitors and evaluates completion of tasks and projects
  • Develops and manages department budget and expenses
  • Conducts briefings and technical meetings for internal and external audience
  • Participate in scientific conferences and make contributions to publications and patents
  • Other duties and responsibilities as assigned
  • Position may require travel to CROs

Job Specification

  • PhD in life sciences, preferably in pharmacology, physiology and/or toxicology
  • A minimum of 15 years (20 years for SVP) experience in preclinical research and development in ocular therapeutics at a biotechnology or pharmaceutical company
  • Experience with managing all aspects of in vivo efficacy, bio-distribution, and safety studies conducted at CROs and academic institutions, preferably in ocular research and drug discovery
  • Familiarity with guidelines required by FDA and other regulatory bodies including experience with IND submissions
  • Excellent writing skills to support communication of preclinical studies and data for scientific, regulatory and IP-related objectives
  • Strong working familiarity with formatting, organizing, managing and analyzing data in MS Excel, SigmaPlot, Graphpad Prism, or similar software/applications.
  • Strong analytical and managerial skills; strong attention to details, able to provide strategic input; good judgment and strong operational focus; well organized and self- directed
  • Strong interpersonal skills with an ability to communicate to people at all levels of an organization

Resumes can be sent directly to:  HR@graybug.com

 

Resumes can be sent directly to:  HR@graybug.com

Graybug Vision is an equal opportunity employer.


Employee Benefit Summary:

Graybug Vision offers the following extensive benefits package in addition to competitive compensation:

  • Medical Coverage (Options for HMO, PPO)
  • Dental and Vision Coverage
  • Life and AD&D Coverage
  • Long-Term Disability Coverage
  • Short-Term Disability Coverage
  • Flexible Spending Account (FSA)
  • 401(k) Retirement Plan
  • Employee Assistance Program (EAP)
  • Additional Life and AD&D Coverage
  • Bonus Compensation
  • Paid Time Off
  • Paid Holidays

Benefits are subject to change at the discretion of Graybug Vision, Inc.