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):

Process Engineer

The Process Engineer will work closely with CMC, Research, and Clinical Development Teams to develop and scale clinical and commercial production processes for the treatment of ocular diseases.  The Process Engineer will tech transfer those developed processes to be executed at contract manufacturing organizations (CMOs).

JOB SNAPSHOT

Posted On: 07/27/2017
Location:  Baltimore, MD
Department:  CMC
Job Type:  Full Time
Education:  Ph.D./ M.S./B.S.
Experience:  0-4+ Years Post-graduate
Travel Required:  Moderate
Salary/Package: To be agreed based on experience; Relocation assistance will be provided if applicable.

POSITION SUMMARY

The Process Engineer will be an integral part of the CMC Department.  This role will be responsible for timely execution of supplies/materials/services at contract manufacturing organizations (CMOs) to meet key project and corporate objectives for various products under development.  They will lead and support technical development of scale up to allow for commercialization of products in development. This role also requires close collaboration with the Preclinical Development and Clinical Development teams to ensure timely delivery of supplies for nonclinical and clinical studies, respectively. The successful candidate will be expected to design and establish production processes. The process engineer must be familiar with emulsion processes, micro/nano-particles, and other polymer drug delivery systems. A degree in chemical engineering, biomedical engineering, materials science, or other related fields is required.  Previous experience in industry is a plus.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Work closely and cross-functionally with internal colleagues on the Research and CMO teams to ensure reliable supply of pre-clinical, clinical, and commercial products
  • Familiar with OSHA standards, ensure compliance with Graybug safety and environmental guidelines
  • Demonstrate serious commitment to personnel and process safety
  • Report safety concerns immediately
  • Participate in safety initiatives and programs
  • Ensure compliance with Graybug quality systems, SOPs, cGxPs, and regulatory compliance
  • Identify/resolve quality concerns and contributing to subsequent investigational reports
  • Contribute to departmental technical/GMP/safety training initiatives
  • Plan and execute batches of sustained-release drug formulations suitable for ocular delivery
  • Characterize unit operations of the current process and optimize processes with an emphasis on improving yield and reducing process variability to support corporate goals
  • Develop conceptual strategies, processing schemes, feasibility studies, PFD’s, mass and energy balances, and detailed scopes of work
  • Experience in process development and technology transfer
  • Support manufacture equipment qualification (FAT/SAT/IQ/OQ/PQ)
  • Seek and qualify beneficial processing technologies
  • Manage equipment total productive maintenance (TPM) program
  • Coordinate required PM/calibration activities for process rooms and equipment
  • Compliance with Graybug policies

EDUCATION AND EXPERIENCE

  • D./M.S./B.S. in chemical engineering, biomedical engineering, materials science, or other related fields is required
  • 0-4+ years post-graduate degree work experience
  • Previous experience in industry is a plus
  • Experience with nanoparticle and/or microparticle formation, especially emulsion processes, strongly desired
  • Research experience in pharmaceutical formulation and/or drug delivery is a plus
  • Ocular drug delivery experience is a plus.

DESIRED KEY COMPETENCIES

  • Execution focused
  • Rapid prototyping and implementation when addressing issues
  • Continuous manufacturing experience with an emphasis on separations
  • Experience in a process development environment using PAT and a fundamental understanding of Quality by Design methodology
  • Other experience with DeltaV and MatLAB
  • Developing capital cost and annual operating/maintenance costs for systems

Interested and qualified candidates are encouraged to send a resume/CV and a cover letter to hiring@graybug.com

Research Associate

The Research Associate will work closely with the Research Team to develop and characterize novel, sustained-release therapeutic formulations for the treatment of ocular diseases.  The Research Associate will design and perform experimental protocols, and prepare scientific reports to support pre-IND and IND activities.

JOB SNAPSHOT

Posted On: 07/30/2017
Location:  Baltimore, MD
Department:  Research
Job Type:  Full Time
Education:  B.S. or M.S.
Experience:  0-3+ Years Postgraduate degree
Travel Required:  Minimal
Manage Others:  No
Salary/Package: To be agreed based on experience; Relocation assistance will be provided if applicable.

POSITION SUMMARY

The Research Associate will be an integral part of the Research Department.  The successful candidate will be expected to perform research studies and prepare scientific reports to support pre-IND and IND activities.  Previous experience in formulation development, micro- and/or nano-particles or other polymer drug delivery systems is strongly preferred.  Previous experience in analytical chemistry and material characterization is a plus.  A B.S. or M.S. in chemical engineering, biomedical engineering, pharmacology and pharmaceutical sciences, chemistry, materials science, or other related fields is required.  Previous experience in industry is a plus.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Function as a member of the Research Team to plan and perform studies to develop and characterize novel, sustained-release drug formulations suitable for ocular delivery.
  • Perform and optimize analytical assays including UV-vis spectrophotometry, HPLC and GPC.
  • Characterize and optimize components of the current process, and devise more efficient methods to support corporate goals.
  • Prepare scientific reports and presentations to support pre-IND and IND activities.

EDUCATION AND EXPERIENCE

  • A B.S. or M.S. in chemical engineering, biomedical engineering, pharmacology and pharmaceutical sciences, chemistry, materials science, or other related fields is required.
  • 0-3 years post-graduate degree work experience. Previous experience in industry is a plus.
  • Research experience in pharmaceutical formulation, and/or drug delivery strongly preferred.
  • Analytical chemistry skills including HPLC, UV-spectrophotometry, GPC, SEM and particle sizing, strongly desired.
  • Experience with nanoparticle and/or microparticle synthesis strongly desired.

DESIRED KEY COMPETENCIES

  • Ability to achieve in a dynamic, fast-paced, multi-tasking environment of a milestone-driven, rapidly changing research environment.
  • Strong verbal and written communication skills and interpersonal skills.
  • 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.

Interested and qualified candidates are encouraged to send a resume/CV and a cover letter to hiring@graybug.com

Scientist/Associate Scientist

The Scientist/Associate Scientist will work closely with the Research Team to develop and characterize novel, sustained-release therapeutic formulations for the treatment of ocular diseases.  The Scientist/Associate Scientist will design and perform experimental protocols, and prepare scientific reports to support pre-IND and IND activities.

JOB SNAPSHOT

Posted On: 07/30/2017
Location:  Baltimore, MD
Department:  Research
Job Type:  Full Time
Education:  Ph.D.
Experience:  0-3+ Years Postgraduate Degree
Travel Required:  Minimal
Salary/Package: To be agreed based on experience; Relocation assistance will be provided if applicable.

POSITION SUMMARY

The Scientist/Associate Scientist will be an integral part of the Research Department.  The successful candidate will be expected to design and perform research studies and prepare scientific reports to support pre-IND and IND activities.  The Scientist/Associate Scientist must be adept at formulation development, micro- and/or nano-particles or other polymer drug delivery systems.  Previous experience in analytical chemistry and material characterization is desired.  A Ph.D in chemical engineering, biomedical engineering, pharmacology and pharmaceutical sciences, chemistry, materials science, or other related fields is required.  Previous experience in industry is a plus.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Function as a key member of the Research Team to plan and perform studies to develop and characterize novel, sustained-release drug formulations suitable for ocular delivery.
  • Develop, perform and optimize analytical assays such as HPLC, NMR and GPC.
  • Characterize and optimize components of the current process, and devise more efficient methods to support corporate goals.
  • Prepare scientific reports and presentations to support pre-IND and IND activities.
  • Seek and qualify new ocular drug delivery technologies.

EDUCATION AND EXPERIENCE

  • A Ph.D in chemical engineering, biomedical engineering, pharmacology and pharmaceutical sciences, chemistry, materials science, or other related fields is required.
  • 0-3 years post-graduate degree work experience. Previous experience in industry is a plus.
  • Research experience in pharmaceutical formulation, and/or drug delivery required.
  • Analytical chemistry skills including HPLC, UV-spectrophotometry, GPC, NMR, SEM, particle sizing, required.
  • Proven assay development and troubleshooting skills required.
  • Experience writing reports and authoring manuscripts as evidenced by a strong publication/presentation record.
  • Experience with nanoparticle and/or microparticle synthesis and characterization strongly desired.

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.
  • Ability to work 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.
  • Good verbal and written communication skills and interpersonal skills.

Interested and qualified candidates are encouraged to send a resume/CV and a cover letter to hiring@graybug.com

Senior Scientist

The Senior Scientist will work closely with the Research Team to develop and characterize novel, sustained-release therapeutic formulations for the treatment of ocular diseases.  The Senior Scientist will design and perform experimental protocols, and prepare scientific reports to support early- and late-stage pharmaceutical development activities.

Location:  Baltimore, MD
Department:  Research
Job Type:  Full Time
Education:  Graduate Degree
Experience:  5+ Years of Industrial Experience in Pharmaceutical Development
Travel Required:  Minimal
Salary/Package: To be agreed based on experience; Relocation assistance will be provided if applicable.

POSITION SUMMARY
The Senior Scientist will be an integral part of the Research Team.  The successful candidate will be expected to design and perform research studies and prepare scientific reports to support early- and late-stage pharmaceutical development activities.  The Senior Scientist must be proficient with formulation development and characterization.  The candidate should also have extensive experience with characterizing the physiochemical properties of different dosage forms and is familiar with in vivo studies using animal models.  Previous experience with drug formulation and delivery, and pharmaceutical development is needed.  A M.S. or Ph.D. in biomedical engineering, chemical engineering, chemistry, materials science and engineering, pharmaceutical sciences or other related fields is required.  A minimum of 5 years of industrial pharmaceutical development experience is required.   Previous experience with commercial drug product design is desired.

ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Function as a key member of the Research Team to design and perform studies to develop, characterize, and optimize sustained-release drug formulations suitable for ocular delivery.
  • Synthesize, characterize, and develop specifications for sustained-release drug products.
  • Optimize drug product design and presentation to support late-stage product development.
  • Characterize and optimize components of the current process, and devise more efficient methods to support corporate goals.
  • Prepare scientific reports and presentations to support all pharmaceutical development activities.
  • Develop, perform and optimize analytical assays.
  • Seek and investigate new technologies to improve product performance and to accelerate product timeline.

EDUCATION AND EXPERIENCE

  • A M.S. or Ph.D in biomedical engineering, chemical engineering, chemistry, materials science, pharmaceutical sciences or other related fields is required.
  • A minimum of 5 years of industrial pharmaceutical development experience is required.
  • Previous experience in pharmaceutical formulation, and/or drug delivery is required.
  • Previous experience with commercial drug product design is desired.
  • Proven assay development, optimization, and troubleshooting skills are required.
  • Experience writing reports and authoring manuscripts as evidenced by a strong publication/presentation record.

DESIRED KEY COMPETENCIES

  • Ability to achieve in a dynamic, fast-paced, multi-tasking environment of a milestone-driven, rapidly changing research environment.
  • Possession of a high degree of personal responsibility and a strong work ethic.
  • Ability to work 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.
  • Demonstration of the highest ethical standards and trustworthiness.
  • Good verbal and written communication skills and interpersonal skills.

Interested and qualified candidates are encouraged to send a resume/CV and a cover letter to hiring@graybug.com

VP, SVP Manufacturing

Job Title: VP, SVP Manufacturing
Department:  Development
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

VP/SVP Preclinical Development

Job Title: VP/SVP Preclinical Development
Department: Preclinical
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

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.