"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.
Noramco LLC., d/b/a Siegfried Wilmington
GENERAL PURPOSE OF JOB
The Program Manager facilitates API (active pharmaceutical ingredient) Technology Transfers and New Product Introductions per the Technology Transfer and New Product Introduction Policy and Procedures. Primary responsibilities include meeting project quality, schedule, and cost deliverables. Oversees and coordinates the operational aspects of projects including the direction and coordination of resources from multiple internal departments. Serves as a liaison with internal and external companies and with trade customers as required.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Prepare and manage project work plans, cost estimates, and status reports.
· Builds a multi-departmental team and leads this team through the execution of the project as described in the Tech Transfer and New Product Introduction (NPI) policies through all stages of the program.
· Cultivates internal relationships and partnerships and serves as project team problem solver, conflict resolution facilitator and meeting facilitator.
· Serve as the subject matter expert for the overall project including, project development, project timelines, budgets, status and interdependencies.
· Communicate project team action items, milestones and key decisions to all levels of the organization as appropriate.
· Prepare and present project status updates to key stakeholders, both internal and external to the organization
· Act as the technical liaison with internal and external customers and suppliers.
· Assist in new and existing process layout and cost estimates.
· Act as project manager for Process Introductions, Process Changes, and other critical company portfolio projects
· Maintains knowledge of cGMPs, process safety practices, environmental standards, and ICH guidelines.
· Create or review development documents, production documents, test procedures, and drug master file sections required for each new process introduction, validation, and regulatory submission.
· May be required to manage multiple programs at various stages within the Technical Transfer/NPI procedure simultaneously.
· Understands and can execute global technical transfers from development to production, from any combination of external and internal facilities.
· Utilize Six Sigma Design Excellence tools to develop project work flows, identify and manage risks, and ensure successful delivery of project Critical to Quality (CQA) attributes.
· Responsible for building internal and external business partnerships with people and departments to effectively support supply chain activities.
· Assist internal and external partners with material receipt and release.
· Assist with supply planning for products related to transfer and/ or manufactured at contract manufacturers.
ADDITIONAL POSITION REQUIREMENTS
· Must be able to work autonomously and anticipate and resolve problems with little assistance or direction.
· 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.
· Comply with safety rules, policies and practices with the intent to maintain a safe working environment. Report all safety incidents, accidents or injuries to supervisor immediately.
· Be available for overtime work on a scheduled or emergency basis.
· Up to 50% travel may be required for introductions at other facility locations.
· Other projects or assignments as requested by management.
SUPERVISORY RESPONSIBILITIES
Leadership for extended team (indirect management).
QUALIFICATIONS
EDUCATION and/or EXPERIENCE
Bachelor degree in Chemistry, Chemical Engineering, or related field with 8-10 years working experience in the pharmaceutical or biotech industry is required. 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
· Interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
· Define 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.
· Must exhibit patience- Ability to listen and check before acting. Is tolerant with people and processes, tries to understand the people and the data before making judgments and acting, sensitive to due process and proper approaches.
· 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.
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: $120,000.00 - $145,000.00 per year
Benefits:
- 401(k) matching
- Dental insurance
- Flexible schedule
- Flexible spending account
- Health insurance
- Health savings account
- Paid time off
- Vision insurance
Application Question(s):
- Are you willing to authorize to obtain employment background report?
Education:
Work Location: In person
