Project Manager

Initial Therapeutics, Inc.; Albany (OH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, Dental, Vision

401K

Generous PTO

Job summary

Siegfried is seeking a Project Manager to lead complex NPD/NPI programs and CDMO projects in a highly regulated pharma environment. You will coordinate an interdepartmental team, manage scope, schedule, cost and quality, and ensure successful regulatory submissions.

Upholding cGMP, safety and environmental standards, you’ll drive project timelines, budgets and risk management while communicating status to senior management. Travel up to 25% may be required.

Qualifications

• Bachelor's degree in Chemistry, Chemical Engineering, or a related field.
• 6+ years working experience in the pharmaceutical or biotech industry is required.
• Project management professional and/or business excellence certifications are preferred.

Responsibilities

• Lead multi-departmental project teams through the NPI/NPD seven-stage program.
• Coordinate resources across internal functions to meet scope, schedule and budget.
• Develop, review and approve development and production documents and test procedures.

Skills

Project management

Cross-functional leadership

Risk management

GMP awareness

Education

Bachelor's degree

Tools

MS Project

MS Office

SAP

Job description

"Expect to grow", personally and professionally: At Siegfried, we offer exciting challenges and ample opportunities to showcase your talents. As a trusted and respected partner to the pharmaceutical industry, we uphold the highest standards in safety, quality and sustainability, while fostering a culture that empowers you to thrive. Join a rapidly expanding global company, where diverse perspectives and experiences come together in a collaborative environment. Here, you'll find a workplace that values both collective success and your individual contributions—offering long-term opportunities to grow and make an impact.

Your Role:

As a Project Manager, leads complex new product development/introduction efforts per NPD/NPI procedures. The Project Manager also leads customer-driven CDMO projects in compliance with the aforementioned procedures as well as the developmental product requirements. Primary responsibilities include leading an interdepartmental project team to meet project deliverables (scope, schedule, cost, and quality), coordinating resources from multiple internal functions to achieve business objectives, and facilitating communication between project team and key stakeholders (customers and upper management).

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 Siegfried).
• Will be required to simultaneously manage multiple projects at various stages within the NPI and Developmental Product procedure.
• 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.

Your Profile:

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.
• Must be able to coordinate multiple project priorities and work effectively across the organization in completing projects on time and in budget.
• Complies with all company and site policies and procedures, carrying out duties in compliance with all state and federal regulations and guidelines, including FDA, EPA, OSHA and DEA.
• 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.

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. Project management professional and/or business excellence certifications are preferred.

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.

Your Benefits:

• Medical, Dental, Vision
• Flexible Spending & HSA Options
• Life Insurance, Short & Long Term Disability
• Pet Insurance
• Generous PTO, Sick & Holiday Time Off
• 401K
• Target Salary Range: $90,000 - 120,000

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.

Additional Benefits

• Medical, Dental, Vision
• Flexible Spending & HSA Options
• Life Insurance, Short & Long Term Disability
• Pet Insurance
• Generous PTO, Sick & Holiday Time Off
• 401K
• Target Salary Range: $90,000 - 120,000

Individual compensation packages are based on various factors unique to each candidate, including skill set, experience, qualifications, and other job-related reasons.

Founded in 1873 in Zofingen, Switzerland, Siegfried has grown into a global network of 16 sites across three continents. With a team of more than 4,200 highly skilled professionals, we take the innovations of our pharmaceutical customers to industrial scale and manufacture safe drugs for patients worldwide. As a fully integrated CDMO, Siegfried is one of the few organizations today that can carry out the development and manufacturing of APIs and finished dosage forms under one roof. This unique combination of know-how and experience makes us the most trusted partner in the pharmaceutical industry.