At Pharmatech Associates, our mission is to fulfill customer expectations throughout the development and execution of tailored, high value, innovation solutions. We are committed to fostering an environment that is professional and forth right. These principles are captured in the values we believe are essential to maintaining our supportive culture and our commitment to our clients’ success. We seek to establish an atmosphere of openness, objectivity, accountability, mutual respect and teamwork so each employee can realize their fullest potential for personal and professional growth. We value work life balance. At Pharmatech talent matters, and we tackle each project with a “no fear” attitude. We stand together as a team, and we’ve got your back. Pharmatech’s commitment to integrity is unwavering.
- The Principal Process Engineer must be a resource to the entire company in terms of technical expertise as an associate to the VP of Product Process Development.
- This position will work closely with the CSO and Pharmatech Project Managers to provide statistical analysis, technical and process guidance and training to the organization and to Pharmatech’s On a project basis this individual could also assume project specific management responsibilities.
- Responsible for identifying opportunities to optimize client’s process technologies and improve quality. This includes data collection and analysis to support new and ongoing process development and scale up activities.
- Support potential new client sales as a technical expert within the organization. This position will estimate project costs, develop proposals, and ensure adhering to project
- Within a short lead time and as required, assume leadership responsibilities anywhere across a client’s
- Develops cost control programs and develops metrics to report project
- Provide broad based consulting services to regulated life sciences clients; such services will include project management as well as execution of project deliverables.
- Serve as a QbD subject matter expert with respect to formulation development, process development, process transfer and scale up, and process validation. This includes solid and liquid dosage forms, liquid and cream products, and biologics including packaging, cGMP systems and requirements.
- Design processes for validation, product/process transfers and continued process verification; including data analysis, gap analysis, identification of critical technical and compliance requirements, technical and compliance documentation review, and process metrics.
- Direct the design and scale-up of pharmaceutical and biotech manufacturing processes, select appropriate instruments and equipment from the laboratory through pilot plant and manufacturing scale-up. Identify opportunities to reduce process variability which includes, but not limited to, conceptualizing and directing equipment solutions and refining /updating procedures and operational checklists and training guides
- This is an individual contributor position which has the capability to manage direct reports within a
- Bachelor or master’s degree with a scientific or engineering related major is required
- Minimum of 10 years’ experience required. Experience within a manufacturing environment for FDA regulated products
- Experience with formal and direct client management in a consulting role
- Knowledge of Quality Target Product Profile, Critical Quality Attributes, and Critical Process Parameters as well as a working familiarity with Quality by Design (QbD) is essential
- Must be current and proficient in newly introduced global concepts, practices, and procedures within the regulated life sciences industry
- Excellent understanding of process design and optimization principles, CMC, root cause analysis methodologies
- Must be proficient with GDP, GLPs, ICH, CFR, and global regulations as appropriate.
- Exceptional personnel management skills and demonstrated leadership capabilities with a proven ability to work cross-functionally within client organizations
- Outstanding English communication (written and verbal) and dynamic interpersonal skills with the ability to work in a team environment and capable of communicating effectively at all levels of management from the executive level (Board of Directors and C-Level) through the operator and analyst level.
- Capable to travel and work remotely at client sites throughout the United States and internationally
- Ability to work in fast pace and demanding environment