This position is focused on biologics manufacturing, which includes processing in upstream (cell culture) and downstream (purification). Operators are expected to perform these processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which apply.
This role will follow an overnight Pitman schedule, 6pm-6:30am.
Duties and Responsibilities
- Perform operations of the following (may be applicable to commercial scale product, development studies, clinical scale or validation activities).
- Operate manufacturing process equipment to perform various manufacturing production steps
- Knowledge on initiating new revisions for procedures
- Proficient operating inside of a BSC, sampling, and performing with aseptic techniques
- Monitor and record batch parameters, including computer data entry. Complete relevant paperwork following GDP/GMP guidelines
- Troubleshoot process problems and respond to alarms. Provide information for unplanned events, including entering data into event management software
- Order, receive and distribute supplies into production area as needed
- Demonstrate procedures as a part of training sessions for other team members; may schedule
- department or process activities which could involve coworkers. Participate in (and may lead, as requested) team meetings and facilitate multidepartment discussions
- Convey information to external stake holders (auditors, global colleagues, etc.). Provide support for groups that support manufacturing
- Participate on Continuous Improvement Teams
- May perform other duties as assigned. (During Production Processing these activities may increase)
- Manufacturing operations tasks requires operator to regularly remain on feet for shift
- Pushing buffer containers ranging from 50L to 200L
- Sitting for periods of 2 to 3 hours
- Demonstrated knowledge of CGMP manufacturing
- Knowledge of laboratory and pharmaceutical production equipment including but not limited to: autoclaves, process tanks, chromatography skids and columns, analytical equipment
- Proficiency in a variety of mathematical disciplines and able to work with both the metric and USA standards of measurement, and military time
- Able to read and follow detailed written instructions and have good verbal/written communication skills
- Able to write legibly and grammatically correct entries on records. Must be able to author technical procedures and create forms
- Familiar with standard troubleshooting approaches (problem statement, root cause analysis, corrections, etc.)
- Good computer skills, knowledge of Microsoft Word, Excel
- Good interpersonal skills and be able to work effectively and efficiently in a team environment
- Ability to meet schedule required; this position may include shift, weekend, holiday work and overtime at times, as dictated by the 365-day per year production schedule
- Ability to work in a clean room environment and comply with hygiene standards and use of special garments
- Additionally, personal protective equipment must be worn due to safety requirements
- Such additional responsibilities as the Company may also assign
Qualifications
- With high school diploma: Normally requires 7+ years of related experience required or an associate degree in Life Sciences/Engineering field. Biotech Certificate preferred
- With Bachelor’s degree: Normally requires 4+ years of related experience
- Good with Microsoft Office – Outlook, Word, Excel
Working Conditions
- Normal office working conditions: computer, phone, files, fax, copier
- Personal Protective Equipment must be worn as required
- May require lifting amounts of 25 lbs
- Manufacturing operations tasks requires operator to regularly remain on feet for shift
Physical Requirements
- PPE as required
- May require lifting amounts of 25 lbs
- Manufacturing operations tasks requires operator to regularly remain on feet for shift
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Base Pay Range
$36/hr - $46/hr
Disclosure Statement
Rentschler Biopharma, Inc is committed to fair and equitable compensation practices. The base pay range listed for this position is the anticipated annual base salary range the organization reasonably, and in good faith, expects to pay for this position at this time. Actual compensation is determined based on several factors that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other application factors permissible by law. The annual base salary is just one component of our Total Rewards package, which also includes our annual discretionary bonus program, medical insurance, our generous 401K program, plus a host of other benefits to aligned to support our employees’ personal and professional wellness. The salary pay range is subject to change and may be modified at any time.
