RQM+ is the leading MedTech service provider with the world’s largest global team of regulatory and quality experts. Building upon 40 years of regulatory expertise, we also provide comprehensive clinical trial, lab and reimbursement services – reducing risk and supporting market access throughout the entire product lifecycle for medical devices, digital therapeutics and diagnostics. With more former FDA, Medicines and Healthcare Products Regulatory Agency (MHRA) and notified body regulators than any other firm, the RQM+ team has deep expertise in all clinical specialties. RQM+ currently works for 19 of the top 20 medical device manufacturers and seven of the top 10 IVD companies.
The Chemist I, Synthetic Production position works closely with other chemists, on-site, to synthesize polymeric resins and prepare analytical columns for distribution. This position will be highly technical. Provide production and lab support for research and development. Must be able to work in a complex, fast paced environment with an ability to prioritize. Organization and attention to detail a must to maintain accuracy and quality of work. Must have good written and verbal communications skills
Responsibilities:
- Reaction synthesis from base monomers to complex polymeric resins. ~1Kg to 50Kg scale.
- Product purification
- Product particle and pore sizing
- Small sale manufacturing of analytical columns
- Performing analyses using analytical instrumentation
- Support technology transfer to scale-up facility by providing shift technical coverage where applicable.
- Participate in project teams directed toward the development of high purity ingredients.
- Ensure scientific integrity and quality of laboratory work they perform and review.
- Prepare and / or review technical reports and standard operating procedures.
- Communicate project status and problems encountered to management.
- Ensure accurate documentation and work in compliance with standard operating and safety procedures.
- Perform peer review of data for other staff members.
- Other duties as assigned.
Requirements:
- BA or BS in Chemistry, Chemical Engineering or applicable life science degree and 0-5+ years industrial laboratory experience related to process chemical development and/or small scale GMP manufacturing. Degreed scientist in an alternative life science field will be considered. Recent graduates with limited experience will be considered.
- Polymer experience or willingness to learn
- Highly motivated and self-driven individual with ability to work independently, and multi-task under aggressive timeline to support team and corporate objectives.
- Proven scientific and technical ability to design and execute synthetic routes, product purification, optimization of chemistry,
- Experience in analytical methods such as HPLC, GPC, Particle sizing, Pore Size
- Maintain and service lab instrumentation and lab equipment.
- Strong awareness of safety of chemicals and reactions
- Adhere to safe laboratory practice.
- In-depth knowledge with organic and polymer chemistry
- Manage time effectively to meet deadlines.
- Coordinate with Quality Control to ensure that required testing is performed and documented to support the disposition of raw materials and finished products.
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results.
- Compile and maintain documentation of laboratory experiments and results, including batch records and standard operating procedure.
- Clean and maintain laboratory instruments and equipment, making sure that all the technology is working correctly, if it isn’t, troubleshoot the issue or problem.
- Order laboratory supplies and chemicals, keeping an eye on expiration dates
This job operates in a professional laboratory environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift or move objects up to 25 pounds and occasionally lift or move objects up to 50 pounds.
Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to focus. Being an industry leader in Medtech is just the beginning for RQM+. We consider our employees our biggest asset and we invest heavily in ongoing learning and development. Providing a rewarding place to work is rooted deep in our core values. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ has a unique offering for regulatory and quality professionals.
At RQM+, you are not just another employee, you are a member of RQM+ family. Make your impact today! We invite you to apply if you have an interest in learning more about our organization and beginning your journey with us.Apply for this job
