New Bioscience Jobs
Sr. Technical Services Specialist
- No
- Job Type: Full Time
Manages the translation of client manufacturing or finishing processes into GRAM. This will include, interpretation of client supplied documentation (i.e. batch records, product inserts, client communications, product proposal, work orders, etc.), translating manufacturing and finishing requirements into GRAM specific batch records, specifications and procedures. Lead and/or work within cross-functional teams to support product introduction, scale-up, development and technical transfer. Will supervise and train Tech. Services Professionals and Technicians. This position works closely with all levels of the Operations (Manufacturing and Finishing), Quality Assurance, Project Management, QC (Microbiology and Analytical Chemistry), Validation and Business Development.
Responsibilities:
- Provide supervision and training to Tech. Services Technicians and Professionals.
- Oversight and development of the batch record, component and material specification creation and revision processes. Responsibilities for GRAM document standardization, compliance resolution, addressing client concerns and meeting project schedules.
- Oversight and development of protocols and summary reports for Engineering, Exhibit, Submission and Registration batches. Review and approve protocols and reports for standardization, content, accuracy and completeness.
- Review and assessment of CAPAs and non-conformance reports, including deviations.
- Review and assessment of Change Control documentation as it relates to Tech. Services.
- Client support/interaction related to the beforementioned processes.
- Conduct the identification and transfer of manufacturing processes from early stage development through transition to commercial manufacturing.
- Provide Subject Matter Expertise (SME) for a board range of manufacturing and finishing processes, including but not limited to compounding, filtration, filling, asepsis, terminal sterilization, inspection, labeling, packaging, etc.
- Open to a flexible and fluid work environment. Work on any assignment as directed and flexibility to support limited multi-shift operations, training and testing.
- Perform all job responsibilities in compliance with applicable regulations, standard operating procedures, and industry practice.
- Support Agency, customer, and vendor audits as needed.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Perform all other tasks, projects, and duties as assigned.
Candidate Requirements/Education:
- Bachelor’s Degree in Life Sciences, related field or equivalent training and/or experience is necessary.
- A minimum of 8 years’ related work experience in a pharma, biopharma, and/or biotech, with experience in manufacturing and/or finishing, preferably an aseptic environment and management experience.
Skills:
- Ability to meet scheduled timelines.
- Supervisory experience with emphasis on personnel training, development and mentoring, problem solving, and working with tightly controlled regulatory documents.
- Demonstrated proficiency for evaluation of drug formulation, aseptic processing, filtration, inspection, labeling, packaging and equipment utilization.
- Competent understanding of FDA, ICH and EMA guidelines and their application for aseptic manufacturing, finishing and processes.
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Demonstrated ability to anticipate client requirements and expectations for manufacturing and finishing documentation, with limited resources spent on re-work.
- Ability to work with a diverse customer and colleague base.
- Strong attention to detail; Ability to complete tasks with accuracy and efficiency.
- Portrays appropriate levels of integrity and professionalism.
- Excellent written and verbal skills; Ability to communicate effectively with management, staff and clients by exhibiting excellent interpersonal skills.
- Results-oriented and efficient; acts with a sense of urgency.
- Has demonstrated ability to lead a cross-functional project team.
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Production Scheduler
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Job Information
- Grand Rapids, Michigan, United States
- 46893976
- February 20, 2019
- Production Scheduler
- Grand River Aseptic Manufacturing
- Production Technician
- No
- Full-Time
Develop and manage the systems required to schedule production at GRAM. This will include coordination across cross-functional teams within GRAM to ensure that the production schedule meets the demands of customers as well as internal processes at GRAM. The position will work closely with project management to ensure GRAM is scheduling production timely in order to meet new products being implemented at GRAM as well as meeting the commercial demand from customers.
Responsibilities:
- Make delivery commitments on products, which involves coordination with project management and customer commitment, checking uncommitted material and availability of capacity
- Ensure coordination with manufacturing, quality, tech services and supply chain teams to execute Production Plan on a weekly and monthly basis
- Monitor actual output vs. the Master Production Plan – identify gaps and drive solutions, including development of a production performance metric.
- Support the implementation and execution of a new production planning software and SOP process to review service levels, capacity availability and performance against schedule.
- Implement and execute a system for receipt of customer purchase orders and scheduling to ensure that production meets the demands from each customers’ purchase order requirements.
- Support Agency, customer and vendor audits as needed.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Perform all other tasks, projects, and duties as assigned.
Candidate Requirements/Education:
- Knowledge of cGMP.
- Direct work experience as a planner/scheduler in a pharmaceutical manufacturing environment; Aseptic manufacturing experience a plus.
- Bachelor’s Degree in business or science.
The level of knowledge required is normally acquired through completion of a Bachelor’s Degree in Business, Life Sciences or a related field and/or a minimum of 5-7 years related work experience.
Skills
- Experience coordinating a cross-functional scheduling process.
- Sound knowledge of supply chain processes and procedures including manufacturing planning, demand, and replenishment processes.
- Proficient in understanding of Production planning.
- Ability to manage complexity and resolve conflicts and production problems.
- Experience working with manufacturing planning software platforms.
- Portrays appropriate levels of integrity and professionalism.
- Excellent written and verbal skills; Ability to communicate effectively with clients, management and staff by exhibiting excellent interpersonal skills.
- Results oriented and efficient; Acts with a sense of urgency.
- Ability to work well independently and in a cross-functional team environment. Efficient team management skills.
- Ability to make sound decisions about scheduling, allocation of resources and managing priorities.
- Proficiency in both written and verbal communication and presentations.
- Energetic, self-motivated, organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
- Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
- Ability to work closely with a diverse customer base (internally and externally).
- Must have proficient computer skills in Microsoft Word, Excel and Outlook.
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