Program Manager

Purisys is a trusted CDMO partner for custom pharmaceutical API and other chemical synthesis projects with capabilities unique in the industry.

Built over a 40-year history, our expertise allows us to support a diverse range of custom API development projects from proof of concept, bench chemistry to full-scale product commercialization – with particular strengths in full-service clinical Phase I/II and small volume, orphan drug commercial API GMP synthesis. Our broad ranging, and often specialized, chemistry capabilities make us the partner of choice for technically intensive and complex projects. Purisys also has an industry-leading track record in compliance with US FDA cGMPs and other global regulatory bodies. For more information on the company please visit https://purisys.com

Purisys offers a generous compensation plan including bonus and 401k matching at $0.75 per $1.00 of employee contribution up to 10% of salary.

GENERAL PURPOSE OF JOB

As a Program Manager, leads complex new product development/introduction efforts per NPD/NPI procedures. The Program Manager also leads customer-driven CDMO programs in compliance with the aforementioned procedures as well as the developmental product requirements. Primary responsibilities include leading a project team to meet project quality, schedule, and cost deliverables. Coordinates resources from multiple internal functions to achieve business objectives. May also coordinate externally contracted work on a project-basis.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following:

· Builds and leads a multi-departmental team and leads the team through the execution of the project as described in the NPI/NPD procedures through all 7 stages of the program (Feasibility to Aftercare). May lead and coordinate work with an external manufacturing network on a project- basis.

· Builds and leads a multi-departmental team from kick-off through completion of customer-driven CDMO projects. Reviews and assists with assembly of proposals for customers.

· Utilize business excellence and/or project management tools/methodology to develop project workflows, identify and manage risks, and ensure successful delivery of project Critical to Quality (CQA) attributes/specifications. Leads development and justification of specifications.

· Cultivates internal relationships and partnerships and serves as project team problem solver, conflict resolution facilitator and meeting facilitator.

· Establish and coordinate with operations the scheduling, permit coordination, capital appropriation, plant readiness, documentation, and SAP set-up for new products.

· Serve as the subject matter expert for the overall project including product development, project timelines, budgets, status and interdependencies.

· Communicate and track project team action items, milestones and key decisions. Communicate to all levels of the organization, as appropriate.

· Prepare and present project status updates to senior management

· Maintains knowledge of cGMPs, process safety practices, environmental standards, and ICH guidelines.

· Review and approve development documents, production documents, test procedures, and drug master file sections required for each new process introduction, validation, and regulatory submission.

· Understands and can execute technical transfers from development to production (both internal and external to Noramco)

· May be required to manage multiple programs at various stages within the NPI procedure simultaneously.

· The ability to work autonomously. Anticipates and resolves problems with little assistance or direction.

· Comply with EHS rules, polices and practices with the intent to maintain a safe and compliant working environment. Report all safety incidents, accidents or injuries to supervisor immediately.

ADDITIONAL POSITION REQUIREMENTS

· May serve as a liaison to external customers or suppliers.

· May serve as a project manager for commercial process improvement projects or line extension efforts.

· Must be able to produce high quality and accurate work in a timely manner to meet the project schedule.

· Must be able to communicate information timely in a clear concise manner.

· Must be able to convey technical information to non-technical audiences.

· Manage and coordinate multiple project priorities and work effectively across the organization in completing projects on time and in budget.

· Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA and DEA. Complies with all company and site policies and procedures.

· Follow all applicable aspects of the site Environmental Management System as it pertains to normal job duties.

· Successfully complete regulatory and job training requirements.

· Be available for overtime work on a scheduled or emergency basis.

· Up to 25% travel may be required for introductions at other facility locations.

· Lead and complete other projects or assignments as requested by management.

SUPERVISORY RESPONSIBILITIES

· N/A – however provides project leadership and oversight.

QUALIFICATIONS

EDUCATION and/or EXPERIENCE

Bachelors degree in Chemistry, Chemical Engineering, or a related field with at least 6 years working experience in the pharmaceutical or biotech industry is required. Advanced education is preferred. Program management professional and/or business excellence certifications are preferred.

Must have the ability to understand and apply knowledge of pharmaceutical active ingredient manufacturing, drug development, drug technology, and project management processes. Previous experience with cGMPs in a FDA regulated site, process safety practices and environmental standards required.

LANGUAGE SKILLS

· Read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.

· Write reports, business correspondence, and procedures.

· Effectively present information and respond to questions

· Technical writing skills

MATHEMATICAL SKILLS

· Apply mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.

· Understands the utilization of control charts and statistical process control.

REASONING ABILITY

· Interprets a variety of instructions furnished in written, oral, diagram, or schedule form.

· Defines problems, collect data or information, establish facts and draw valid conclusions.

OTHER SKILLS ABILITIES OR QUALIFICATIONS

· Must be able to work effectively with others and with minimal supervision.

· Manage and coordinate multiple project priorities.

· Strong computer skills with hands on experience with MS Office (Excel, Word, Project, etc.)

PHYSICAL DEMANDS

· While performing the duties of this job, the employee is frequently required to stand; walk; use hands to finger, handle, or feel.

· The employee is occasionally required to sit; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl.

· The employee must occasionally lift and/or move up to 10 pounds.

· Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.

Purisys is an equal opportunity employer. Qualified applicants will be considered without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability or any other protected class.

Job Type: Full-time

Pay: $110,000.00 - $130,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Compensation package:

• Bonus opportunities

Schedule:

• Day shift

Application Question(s):

• Are you willing to undergo a background check, in accordance with local law/regulations?

Education:

• Master's (Preferred)

Experience:

• pharmaceutical or biotech industry: 6 years (Preferred)

Work Location: In person

Salary : $110,000 - $130,000