Senior Scientist, Process Development

Responsibilities:

Independently work on multiple steps/multiple projects to execute multiple chemical syntheses from hundreds of grams to kilos scales and conduct pilot scale synthesis (kilo scale) purification and characterization of compounds and present results and progress updates to internal and external stakeholders, stay abreast of current literature in scientific areas, maintain equipment, chemical inventory and lab support and Perform duties as required. The incumbent works cross-functionally with internal departments and external resources on process development related issues. The Senior Scientist in Process Development supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. 

• Performs laboratory chemical development of robust, safe, and scalable processes for operation in Kilo-lab independently.
• Design, synthesis, and purification of compounds (small and complex molecules, payload, linkers, APIs, etc.) – typically 5-7 reactions including pilot and scale up with 3-5 purifications weekly.
• Participates regularly in cross functional project teams within Research and Development and with external clients (mg to multi-gram scale projects) and in group meetings and communicates results, data, verbally and written.
• Works independently on kilo-lab equipment to prepare pharmaceutical intermediates and Active Pharmaceutical Ingredients (APIs) and highly potent APIs (HPAPIs) and performs purifications using normal phase and reverse phase chromatography systems.
• Applies technical knowledge to safely optimize synthetic organic chemistry processes for scale up into large glassware, supports and works on pilot plant tech transfers projects and for multiple batch use for APIs, and HPAPIs independently.
• Regularly characterizes molecules using analytical techniques including NMR, MS, HPLC, LCMS and providing clients with high-quality technical documents (SDS, COCs, product data sheets, reports, etc.) in an accurate manner.
• Researching synthetic routes through literature searches and search databases.
• Documenting experiments in notebooks accurately and following site GDPs.
• Ordering materials correctly for projects, chemical inventory and safe storage of chemicals.
• On-site Training, and maintaining safety, GLPs, and GMPs, as needed.
• Following safety protocols while handling cytotoxins, properly disposing solid and solvent waste.
• Supervising scientists, includes mentoring, developing and training, monitoring their progress on projects.
• Supporting lab equipment as needed and safety inspections as needed.
• Perform other tasks and assignments as needed and specified by management.

Requirements:

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 optimize synthetic organic chemistry processes for scale up of APIs, HPAPIs at pilot scale is needed.
• Has a working knowledge of cGMP process scale-up and familiarity with compliance requirements within cGMP, SOPs, and regulatory environments.
• Demonstrates a willingness to learn and work pro-actively.
• 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.
• Knowledge of literature search databases and ChemDraw.
• 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 fulfill the business need.

Education and Experience Requirements:

• PhD/MS level in Organic Chemistry
• 2-4 plus years of industrial experience in pharmaceutical process development for scale up of intermediates and APIs into Kilo-lab and pilot plant facilities (GMP)
• 3 or more years industrial experience developing processes for scale-up of small molecule pharmaceuticals or HPAPI chemicals is preferred (GMP)
• Experience in a CRO or CMO environment is desirable

Physical Demands:

Occasionally required to lift or move objects up to 40 lbs

Working Conditions:

On-site only, in laboratory majority of time and in office

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.