Job description

BioDevelopment is looking for a Director level General Manager to lead our Rensselaer, NY team. The ideal candidate will be a can-do leader, who is willing to roll up his or her sleeves, and build a startup process development organization which supports the mission of a larger organization called BioSpectra.

This candidate should have experience developing pharmaceutical and/or chemical ingredients for the life science or bio-pharma industries. In building this start-up process development organization, this individual will assume a key leadership role in accelerating the continued growth of a Company that supports the top 25 pharmaceutical companies in the world.

BioDevelopment shares the same ownership of BioSpectra which is a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including API’s, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioDevelopment is located in Rensselaer, NY. BioSpectra currently has facilities located in Bangor, Wind Gap and Stroudsburg, PA.

Our Mission:

To manufacture the highest quality Pharmaceutical ingredients under the supervision of the most rigorous quality system while upholding the most stringent compliance standards

Our Vision:

A world with safe & effective drugs that deliver consistent, reliable therapeutic effect with every dose

Our Values:

Quality / Integrity / Respect

Oversee the BDI facility, employees, materials and equipment to ensure efficiency is maintained and projects remain on schedule for development and manufacturing projects. The General Manager is responsible for all facility operations performed at BioDevelopment Inc. This role is responsible for ensuring successful and timely development and implementation of efficient processes to support the continued growth and expansion of BioDevelopment Inc.

Key Responsibilities:

• Manages and supports all BDI employees including daily performance, disciplinary actions and ensuring employee welfare.
• Leads all aspects of Bio Development’s manufacturing and site Operations to ensure business growth and continuity.
• Manages the portfolio of projects for all products in the pipeline.
• Leads all employees to facilitate chemical research through to manufacturing for all materials at BioDevelopment Inc. from synthesis to finished Excipients and Active Pharmaceutical Ingredients.
• Conducts meetings with employees to ensure work is properly delegated and deadlines are met.
• Prioritizes projects and ensure they remain on schedule.
• Oversees the health and safety of employees at the Rensselaer facility.
• Directs the transition of materials from discovery to commercial manufacturing, include scale-up activities and technology transfer reports.
• Sources all materials necessary for development and manufacturing.
• Manages the selection of equipment and final decision on process workflow to ensure controlled manufacturing of BioDevelopment products meeting established and approved specifications.
• Directs manufacturing personnel to ensure successful manufacturing of all products supplied through BioDevelopment Inc.
• Directs and leads the facility operations to ensure the accurate and timely completion of activities in Development, Manufacturing, and Operations.
• Manages the development requirements for new products and continually reviews and reports on the progress of new processes built in accordance with cGMP requirements.
• Ensures all development operations and finished material manufacturing is performed in accordance with applicable regulatory guidance documents such as ICH Q7, ICH Q11 and Process Validation.
• Ensures that commercial supply of finished material from Bio Development is planned and managed to prevent shipment delays.
• Participates in management meetings with other members of the senior management team to establish, delineate, and review organizational policies, to coordinate functions and operations between departments and company locations, and to establish responsibilities and procedures for attaining objectives.
• Manages the BDI facility and ensures the facility remains regulatory compliant and functional.

Qualifications:

• Experience in life science, chemical and/or pharmaceutical ingredient manufacturing.
• Bachelor of Science degree in science and/or engineering degree or related educational experience is preferred.
• Effective working knowledge of process development in cGMP environment.
• Knowledge of the requirements and applicable pharmaceutical ingredient, regulatory and industry standards.
• Demonstrated leadership ability to build an effective team.
• Effective critical thinking, decision-making and problem-solving skills.
• Effective verbal and written communication skills.

If you are looking for a challenge to build a startup process development organization within a larger successful organization, you’ve come to the right place.

Apply on our Career Website: https://www.biospectra.us/about-us/career-opportunities/61?view=joblisting

Job Type: Full-time

Pay: From $110,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance

Schedule:

• 10 hour shift
• 12 hour shift
• Monday to Friday

Supplemental pay types:

• Bonus pay

Ability to commute/relocate:

• Rensselaer, NY 12144: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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