Inclusively is partnering with a pharmaceutical and biotechnology corporation to hire a Technical Specialist, Clinical Manufacturing. **Please note: this role is NOT an internal position with Inclusively but with the partner company.**

ABOUT INCLUSIVELY:

Inclusively is a digital tech platform that empowers job seekers with disabilities, caregivers, and veterans by using Success Enablers–accommodations and personalized workplace modifications that help all job seekers reach their full potential and excel. This includes all disabilities under the ADA, including mental health conditions (e.g. anxiety, depression, PTSD), chronic illnesses (e.g. diabetes, Long COVID), and neurodivergence (e.g. autism, ADHD).

Create your profile, select Success Enablers, and connect to jobs from our partnered employers who are committed to creating diverse and inclusive teams. When registering, you must acknowledge that this platform is for people with disabilities, caregivers, and veterans. However, Inclusively does not require candidates to disclose their specific disability to join the platform.

As part of the Technical Operations team, your prior work experience and ability to apply your breadth of knowledge will help you adapt the standard methods and procedures. You will help us identify required delivery and process improvements that drive increased efficiency, throughput and quality. You will arrive at decisions on which methods and procedures are the best fit for different work situations.

It is your hard work and focus that will help in making our company ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

• Manage own time, professional development, and be accountable for own results.
• Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.
• Adhere to Good Manufacturing Practices and standard operating procedures, and material sampling instructions.
• Execute downstream mammalian and microbial purification processes in a {Current} Good Manufacturing Practices {part of GxP} environment.
• Responsible for the equipment preparation, formulation and filling of biologic drug products.
• Complete recurring assignments independently and select the most appropriate method or approach to do so within prescribed limits of authority.
• Identify opportunities for continuous improvements and enable implementation, utilize continues improvement and root cause analysis tools.
• Maintain cross-functional communication with tech transfer team, quality and engineering.
• Perform troubleshooting of production support equipment and operations.
• Understand scientific principles in order to problem solve and troubleshoot test results.
• Report any deviation or observation that might lead to adverse impact to product quality.
• Complete work instructions and maintains clean room environment to comply with regulatory requirements.

Qualifications

Must-Have

• High School Diploma or GED.
• 2+ years of experience.
• Certification in assigned area, if applicable.
• Demonstrated experience in a biotechnology manufacturing or laboratory environment.
• Experience in cGMP (Current Good Manufacturing Practices) compliance as related to manufacture of biologics.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Strong workload planning skills, organization, and attention to detail, and follow through.
• Excellent written and verbal communication skills.
• Strong computer skills in Microsoft Office required e.g. MS Word, MS Excel.

Nice-to-Have

• Bachelor's Degree.
• DS Purification experience.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Ability to effectively gown into and operate in a clean room environment for extended periods of time. Gowning may include full coveralls, face mask, head cover, boots and gloves.
• Ability to work non-standard hours as required including occasional evenings or overnights or weekends. Typical work schedule is 7AM – 330PM M-F. Non-standard hours are typically on a volunteer basis and are avoided when possible, however it is unavoidable at times.
• There is no travel expected with this role.

Other Job Details:

• Last Date to Apply: November 04, 2024.
• Geography includes: USA - MA - Andover
• Eligible for Relocation Package - NO

The salary for this position ranges from $28.68 to $47.79 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company’s policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with company Matching Contributions and an additional company Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Our compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States - Massachusetts - Andover location.

Relocation assistance may be available based on business needs and/or eligibility.