Production Spec, Mfg & Process Improvmt
|Post Date:||Apr 21, 2017||Type:||Full-Time|
|Start Date:||4/21/2017||Salary:|| |
At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.
We strive to be the leading supplier using science and technology to improve the quality of life.
We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.
Do you want to help us as we shape the future of this great organization?
Job Description Summary
Responsible for improving products within the RTS product line. In addition, performs work activities associated with Endotoxin Detection Systems formulations, component formulations, in-process lysate testing, raw materials testing, final product testing, and vialing and lyophilization of lysate within the requirements of GMP and ISO 9000 regulations.
- Directly support the manufacturing process by testing, experimentation, and reviewing data. Key member of the LSS process within the RTS group.
- Performs endotoxin formulations and component formulations as well as in-process, raw material and final product testing in a Class 100 environment.
- Executes product development and organizes experimental results.
Work with our Statistician to set-up experiments that help to improve production processes for current products. Use MiniTab where appropriate.
Work with our Project Manager to execute product improvement experiments.
Provides primary training of personnel in procedures related to both endotoxin detection systems and formulation.
- Writes and revises SOP’s, specification sheets, and DMR’s. Provide data in support of FDA submissions.
Manages upkeep of departmental equipment.
- Resolves problems. Maintains adherence to company policies and procedures.
- Participates in Customer Audits as needed.
- Assists with Special Projects as needed.
Maintenance of quality systems and cGMP compliance for the business by ensuring that all team members comply with processes, procedures and instructions for all activities in which the team participates.
- Is knowledgeable and complies with all pertinent safety policies, rules and regulations.
- Ensure that all team members comply with safety rules and regulations.
Provides appropriate coaching and performance feedback to all direct reports and assures that all team members are being developed.
Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Performs testing to drive product improvements. Ensures schedules and performance requirements are met.
Skill and/or Education Requirements
- Bachelor’s Degree in Life Sciences or related discipline and at least 10 years experience in a laboratory environment and thorough understanding of laboratory procedures and equipment.
- Knowledge of biology, chemistry, statistical analysis, technical writing
- Knowledge of basic specialized laboratory equipment including laminar flow hoods, centrifuges, spectrophotometers, incubators, fluorescent and phase contrast/bright field microscopes and microphotography equipment.
- Time Management, facilitation skills, delegation skills, computer software skills (specifically databases, spreadsheets, statistical software, and Microsoft Office), organization, record keeping and planning skills, training skills, multiple projects, time management, facilitation skills
- Diplomacy, negotiation skills, written and oral communication, team building skills, independent work skills, strong work ethic, coaching, delegating skills
A majority of the work is done in a laboratory environment. While working in the laboratory a lab coat is required along with appropriate safety equipment as denoted for the designated area (i.e. safety shoes and/or shoe covers, hair cover, gloves, safety glasses, gown). Work also includes the use of a computer. Meetings are held in conference rooms or other suitable locations.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
Lonza. The place to Go, Stay and Grow.
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