Analytical Development Biotech Jobs in Silver Spring, MD

ABOUT THE POSITION:

Become a biotechnology startup leader and bring cutting-edge, novel therapeutics to patients with great unmet medical needs.

ABOUT THE COMPANY:

Globin Solutions, Inc. is a pre-clinical stage biopharmaceutical company that is committed to researching and developing a rapidly acting antidote for carbon monoxide poisoning, artificial blood products, and medical countermeasures. Globin is aggressively developing its lead compound through preclinical testing with the goal to pursue regulatory clearance for clinical testing. Globin partners with experts in globin chemistry and protein engineering through academic partnerships to further develop their pipeline of agents for carbon monoxide poisoning and other indications. Globin highly values integrity, innovation and a commitment to patients.

JOB RESPONSIBILITIES:

Scientific Development Role

• Development leader for drug candidates in carbon monoxide poisoning, artificial oxygen carriers/artificial blood, medical countermeasures, and cardiovascular disease
• Key contributor for drug development and protein engineering programs
• Development and optimization of protein and small molecule therapeutic manufacturing
• Leads work activities in research and development program by planning and organizing work, providing for adequate resources, and maintaining work on schedule so that ongoing research and development progress is satisfied
• Develop and maintain R&D laboratory budget, policies and procedures.
• Communicates with collaborative partners (e.g. sponsored research partners, regulatory consultants, contract research organizations and contract manufacturing organizations) to coordinate work and resolve issues as needed.
• Leads maintenance of laboratory equipment and other technical resources. Coordinates with internal personnel, vendors, and others as needed to resolve issues and maintain proper workflow.
• Prepares reports, presentations, and other information summarizing work activities.
• Maintains laboratory notebook and appropriate regulatory documentation.
• Prepares and updates SOPs to define laboratory operating procedures.
• Prepares various analyses as needed to highlight issues and resolve problems.
• Work with suppliers to maintain adequate resources, reagents and supplies to continue research operations.
• Participates in the preparation of documentation packages for regulatory submissions (including pre-IND, IND) to the FDA and other regulatory agencies.
• Formats, edits, coordinates and reviews regulatory documentation for inclusion in pre-INDs, INDs, and other worldwide submissions.
• Compiles documentation for submissions to FDA and foreign regulatory agencies.
• Maintains regulatory documentation including submissions to and correspondence with each governing authority.

Business Development Role

• Major contribution to fundraising mission and non-dilutive grant funding.
• Prepares scientific and business plan decks and documents.
• Interactions with existing and potential investors.
• Prepares, organizes, assists in writing government and foundation grants for non-dilutive funding opportunities.
• Grants management and compliance management.
• Reviews technical documentation for regulatory compliance.
• Assessment and continued development of new therapeutic indications of existing intellectual property portfolio.
• Performs other appropriate administrative duties, such as preparing correspondence (records of contact), filing, quality management system support, where necessary.
• General business operations management.

EDUCATION:

• B.S.E., M.A, M.S., or Ph.D. degree in an appropriate scientific, engineering or other related field

AND/OR

• M.B.A. degree with an undergraduate degree in a scientific, engineering or other related field

REQUIRED EXPERIENCE, SKILLS AND ABILITIES:

• Two to four plus years’ experience in Pharmaceutical/Biotechnology industry or applicable field or academic background is highly desirable.
• Interest in drug development, product engineering, product manufacturing, and drug discovery.
• Experience in recombinant protein production and/or drug manufacturing and synthesis.
• Self-starter and able to work independently with reliable work product and maintaining a schedule.
• High organizational skills.
• Experience in scientific writing and grant writing.
• Quantitative analysis skills.
• Strong written and verbal communication skills for investor and stakeholder relationship building.
• Talent in scientific communication and public speaking.
• Fundraising and basic finance knowledge.
• General business and marketing knowledge or experience.
• Experience/knowledge in operations.
• Research administration experience.
• Extensive experience with Microsoft Word, Excel, and PowerPoint.
• Ability to work in collaborative, multidisciplinary, and distributed teams.
• Flexibility to work in a startup environment.

PREFERRED (NOT REQUIRED) EXPERIENCE AND QUALIFICATION:

• Experience with drug or diagnostic development programs.
• Experience working in multidisciplinary teams.
• Experience with working within the FDA regulatory framework.
• An advanced research degree.
• Experience in scaling up life science startup companies.
• Work in technology startup space.

PHYSICAL DEMANDS:

• Extensive sitting, standing and computer use.
• Extend and reach with hands and arms and use hands and fingers.
• Occasionally required to climb, balance, bend, stoop, kneel or crouch.
• Climb stairs.
• Fluency in the English language
• Travel could be required for conferences, presentations, and investor meetings.

WORK ENVIRONMENT:

• General office environment.
• Research laboratory environment.

JOB-TYPE

• Full-time, 40 hours per week
• Part-time schedule possible
• Hybrid work potential with regular in-person component

BENEFITS

• Health insurance, employer sponsored supplement
• Paid time off