Project Manager

SIEGFRIED USA LLC - 3.4

Athens, GA Job Details Full-time $95,000 - $115,000 a year 3 hours ago Benefits Health savings account Disability insurance Health insurance Dental insurance 401(k) Flexible spending account Paid time off Vision insurance 401(k) matching Life insurance Qualifications EHS Statistical Process Control Technical writing experience within manufacturing Environmental compliance GMP Microsoft Office Manufacturing facility experience Bachelor's degree Pharmaceutical company experience Managing projects Algebra Environmental regulatory compliance Environmental safety protocols Pharmaceutical manufacturing facility experience Full Job Description 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.

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.
• 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. We offer a comprehensive and competitive benefits package designed to support your health, wealth, and work-life balance: Medical, dental, and vision coverage (including dependents) Life insurance, short and long term disability Flexible Spending Accounts (FSA) & Health Savings Accounts (HSA) 401(k) with company match Generous Paid Time Off (PTO) Targeted Salary range: $90,000-$115,000 The job demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This job description is not intended and should not be construed to be an exhaustive list of all responsibilities, skills, efforts, or working conditions associated with the job. It is intended to be a reflection of those principal job elements essential for recruitment and selection, for making fair job evaluations and for establishing performance standards. The percentage of time spent performing the various job duties are not absolute. The incumbent shall perform all other functions and/or be cross trained as shall be determined by the sole discretion of management, who has the right to amend, modify, or terminate this job in part or in whole. This document is not a contract for employment.

Pay:

$95,000.00 - $115,000.00 per year

Benefits:

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

Work Location:

In person