Process & GMP Manufacturing Chemist III Position Available In Mercer, New Jersey

Process & GMP Manufacturing Chemist III NJ Bio, Inc. – 1.0 Princeton, NJ Job Details $100,000 – $110,000 a year 1 hour ago Benefits Health insurance Paid time off Retirement plan Qualifications CGMP 6 years Management Doctoral degree Organic chemistry Bachelor of Science Laboratory experience GMP Spectroscopy Microsoft Office Master’s degree Supervising experience Quality assurance Bachelor’s degree Doctor of Philosophy Organizational skills Cleanroom Senior level Communication skills Time management Full Job Description Works on multiple steps/multiple projects to execute chemical syntheses from mgs to grams to kilo scales and conduct pilot scale synthesis (kilo scale), purification and characterization of compounds and present results and progress updates to internal and external stakeholders, maintain and clean ab equipment, ensure GMP room maintenance, MBR writing, and perform manufacturing-related activities. The candidate works cross-functionally with internal departments and external resources on process development and GMP manufacturing related issues. The Process & GMP Manufacturing Chemist III supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. Should be flexible with small scale and manufacturing execution. Perform hands-on laboratory chemical development of robust, safe, and scalable processes for operation in Kilo-lab, pilot plant and GMP suite. Participate regularly in cross functional project teams within Research and Development and with external clients as needed (on mg to multi-gram scale projects). Works on kilo-lab equipment to prepare pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) and highly potent APIs (HPAPIs) under supervision until fully trained. Applies technical knowledge to safely execute synthetic organic chemistry processes for scale up into large glassware, supports and works on pilot plant tech transfers projects for APIs, and HPAPIs. Maintain GMP lab equipment and instruments, MBR writing/review and execution plan. Documentation of deviations & CAPAs. Maintain GMP room status and cleanliness Performs pilot scale purifications using Teledyne ISCO purification and Torrent system Performs GMP manufacturing of small molecules/ nucleic acids/ antibody conjugate. Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills and Abilities:

Must have full working knowledge of and practical experience with analytical instruments and analytical techniques including HPLC, mass spectroscopy, NMR, and purification systems such as Teledyne ISCO purification and Torrent system. Technical knowledge to safely work on synthetic organic chemistry processes for scale up of APIs, HPAPIs at pilot scale is needed. Good interpersonal skills to be an effective member of a multi-disciplinary team of chemists, bioconjugation, analytical and quality assurance specialists. Has a working knowledge of cGMP process scale-up and familiarity with compliance requirements within cGMP, SOPs, deviations, CAPA and regulatory environment. Well versed with GMP lab equipment and instruments. Be able to organize work efficiently such that several operations can be carried out simultaneously. Ability to be a collaborative team member. Ability to apply critical thinking and have good problem-solving skills. Demonstrates a willingness to learn and work proactively. Able to communicate scientific data effectively through presentations, notebooks, and reports. Maintain a culture of safety and ensure safe work practices within the lab. Adheres to company EHS and quality standards, regulations, and company policies, procedures, and mission. Communicates effectively with supervisors and colleagues. Proficiency with Microsoft Office Excellent verbal and written communication skills as well as interpersonal skills. Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members. Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines. Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfil business need.

Education and Experience Requirements:

PhD/MS/BS level in Organic Chemistry with at least 6 years of industry experience in pharmaceutical process development for scale up of intermediates and APIs into Kilo-lab, pilot plant and GMP facilities Industrial experience developing processes for scale-up of small molecule pharmaceuticals or HPAPI chemicals is preferred. Experience in a CRO or CMO environment is desirable.

Physical Demands:

Ability to work in a cleanroom environment, adhering to strict safety and cleanliness protocols. Ability to lift and carry materials up to 30 lbs and perform tasks that may require standing for extended periods. Must be willing to work 10-hour shifts using PPEs including PAPRs and must be gowned when inside process suite. Physical dexterity sufficient to use pipettes, laboratory equipment, computers and documentation. Sufficient vision and hearing capability to work in job environment. Must have the ability to work in laboratories and controlled, enclosed, restricted areas. Cleanroom garments and personal protective equipment will be required in designated areas which cover head, parts of the face, core body, and legs/feet including PAPRs Jewellery, makeup, gum, nail polish, perfume/cologne and other potential microbial sources are prohibited in restricted areas. Flexibility to don clean room garments and personal protective equipment (PPE) and PAPRs. The manufacturing environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected. Restricted areas prohibit food, any outside materials such as cell phones, tablets, at a minimum.

Working Conditions:

This role will primarily be based in the GMP manufacturing facility, with periodic office-based work for reporting and cross-functional collaboration. Additional Information This position may require shift work, weekend or holiday hours, or on-call responsibilities depending on the production schedule. Training in GMP will be provided as needed. The company offers competitive benefits, including health insurance, retirement plans, and paid time off.

Compensation:

$100,000- $110,000 per annum NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.