Job description

The Director of Process Technologies will oversee activities required for the successful execution of Process Technologies projects, provide recommendations to Leadership, and assist with training Manufacturing personnel in both the how & why as production processes are transferred to Manufacturing.

Essential Duties and Responsibilities:

• Leads all aspects of BioSpectra’s Process Development from technology transfer through completed process validation to support the development and implementation of new products or processes at each BioSpectra facility.
• Responsible for leading the process development team to continue building and enhancing process development, scale-up and successful Process Validation studies.
• Ensures the compliant execution of Process Development, Validations, process evaluation, and cleaning validation.
• Builds the procedures and policies necessary for the success of Process Technology operations.
• Leads the transition of materials from discovery to commercial manufacturing, include scale-up activities and technology transfer reports.
• Sources all materials and equipment necessary for development, technology transfer and scale-up to Manufacturing.
• Manages the selection of equipment and final decision on process workflow to ensure controlled manufacturing of BioSpectra products meeting established and approved specifications.
• Creates, reviews and approves validation master plan and protocols, qualification master plan and protocols in accordance with the FDA guidance on Process Validation.
• 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 and validation activities are performed in accordance with applicable regulatory guidance documents such as ICH Q7, ICH Q11 and Process Validation.
• Participates in leadership meetings 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.
• Other duties may be assigned by the President of BioSpectra.

Qualifications:

• Bachelor of Science degree in Science related field or equivalent experience and a minimum of ten years related experience in process technology or validation and qualification.
• Understanding of process development, process validation, cleaning validation, equipment qualification, and cGMP,
• Knowledge of the requirements of applicable regulatory and industry standards.
• Ability to effectively present information to Senior management and other groups.
• Strong verbal and written communication skills
• Strong interpersonal skills with the ability to build and maintain strong working relationships.
• Strong leadership and supervisory skills.
• Strong analytical and problem-solving skills.
• Ability to respond to security incidents at any time, as appropriate.

Physical Requirements:

• Lift up to 20 lbs. occasionally
• Prolonged periods sitting at a desk and working on a computer
• Ability to see and distinguish color
• Bend, stoop, and carry
• Repeating motion that may include wrists, hands, and fingers

Work Hours & Schedule:

The Director of Process Technologies will be required to work a minimum of 45-50 hours per week and is a salaried position. Extenuating circumstances may require additional time for certain periods. It is widely assumed that displacement of hours and/or days will occur on recurring and non-patterned bases. This job function may include travel. This BioSpectra function may require the ability and willingness to travel to the Bangor, PA, Stroudsburg, PA, Wind Gap, PA or Rensselaer, NY Facilities.

Job Type: Full-time

Pay: From $125,000.00 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:

• Bangor, PA 18013: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Management: 1 year (Preferred)

Work Location: One location

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