Off Targets is a leader in pharmaceutical innovation, committed to developing advanced therapeutic solutions that address unmet medical needs. We are looking for an experienced and dynamic professional to lead our Formulation Development department, driving the development of cutting-edge injectable drug products. Job Description We are seeking an accomplished R&D leader to head our Injectable Formulation Development function. The ideal candidate will bring deep technical expertise in complex injectable products and a strategic mindset aligned with 505(b)(2) development, regulatory planning, and IP differentiation. Key Responsibilities: Lead end-to-end formulation development of complex injectable drug products (liposomes, emulsions, depot injections, suspensions, etc.). Design and drive a robust R&D pipeline focused on 505(b)(2) opportunities . Provide strategic input into USFDA regulatory planning (CMC sections, QbD, stability). Contribute to patent strategy and product differentiation from early development. Collaborate with analytical, regulatory, IP, and business development functions. Mentor a high-performing R&D team and build scientific leadership. Solve scale-up and technology transfer challenges. Maintain strong compliance with global quality and documentation standards. Key Skills: Injectable Formulation, 505(b)(2), Liposomes, Emulsions, Depot Injections, Formulation R&D, CMC, USFDA, Drug Delivery, Intellectual Property, Team Leadership, Innovation Strategy Desired Candidate Profile: Qualification: Ph.D. / M.Pharm in Pharmaceutics or related field Experience: 15+ years in pharmaceutical R&D with at least 5 years in a strategic leadership role Proven expertise in injectable formulations and 505(b)(2) development Strong knowledge of USFDA CMC expectations, IP evaluation , and regulatory submission processes Excellent leadership, innovation, and cross-functional collaboration skills Perks and benefits Opportunity to lead a key department in a forward-thinking pharmaceutical company. A collaborative and supportive work environment that encourages professional growth and innovation. Competitive salary and benefits package, with opportunities for advancement. Access to state-of-the-art facilities and cutting-edge technology. How to Apply: Interested candidates are invited to submit their resume and a cover letter outlining their experience and qualifications to business@offtargets.com

Job Description We are looking for an experienced and dynamic Team Leader to head our Analytical Research team within the Pharmaceutical R&D division, focused on complex injectable products and 505(b)(2) submissions . This role is ideal for a candidate with a strong background in pharmaceutical R&D , robust team management skills , and deep understanding of injectable formulation analytics . Key Responsibilities Lead and manage the analytical research team supporting complex injectable development. Supervise daily lab operations, resource allocation, and project timelines. Drive method development, validation, and troubleshooting for injectable formulations. Provide scientific leadership and ensure data quality and regulatory compliance. Maintain high team morale and cultivate a positive, collaborative work environment. Guide preparation of analytical documents for regulatory filings (505(b)(2), ANDA, etc.). Impart training, develop team capabilities, and mentor junior scientists. Collaborate closely with formulation, quality, and regulatory teams. Ensure compliance with cGMP, GLP, and internal SOPs. Desired Candidate Profile Qualification: M.Pharm / Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, or related field. Experience: 8+ years in Pharmaceutical R&D , minimum 3 years in a leadership/supervisory role . Hands-on experience in analytical method development for complex injectables (liposomes, suspensions, emulsions, etc.). Sound knowledge of 505(b)(2) regulatory pathway . Strong command of analytical techniques: HPLC, GC, spectroscopy, particle size analysis, etc. Proven track record in team leadership, project coordination , and technical problem-solving . Excellent communication and interpersonal skills. Key Skills Analytical R&D, Complex Injectables, Injectable Formulations, Team Management, 505(b)(2), Method Development, HPLC, GC, Troubleshooting, Pharmaceutical R&D, Training & Mentoring

Job Description Off Targets Research Private Limited (OTRPL) is seeking a proactive and detail-oriented Quality Assurance Executive to support our fast-paced R&D operations , with a focus on complex injectable product development . This role is ideal for candidates with 2-4 years of experience in QA functions within pharmaceutical R&D , particularly those with exposure to method development, formulation development, and regulatory documentation for global markets. Key Responsibilities: Review and approval of analytical and formulation development documents (protocols, reports, notebooks, method validation reports, etc.) Oversight of R&D documentation practices to ensure compliance with internal SOPs and regulatory standards (cGMP, GLP, ICH, etc.) Support data integrity initiatives and routine internal QA audits within the R&D environment Assist in deviation and change control reviews during the development phase Ensure proper archiving and traceability of scientific records and batch documents Coordinate with cross-functional teams (formulation, analytical, regulatory) to ensure QA alignment from early development to exhibit batches Contribute to regulatory submission readiness (505(b)(2), ANDA, EU hybrid, etc.) Desired Candidate Profile: Qualification: B.Pharm / M.Pharm / M.Sc. (Pharmaceutical Sciences, Chemistry, or related field) Experience: 2 to 4 years in a pharmaceutical QA role, ideally within R&D or development-phase QA Familiarity with complex injectables is preferred Strong understanding of QA documentation practices , ICH guidelines, and R&D phase compliance Experience in working with method validation, formulation trials, and raw data review Detail-oriented, process-driven, and comfortable working in a collaborative R&D setting

Role & responsibilities Position Summary: As an Analytical Scientist at Off Targets Research, you will play a crucial role in the development and validation of analytical methods for the characterization of pharmaceutical products. You will work closely with cross-functional teams to support the research, development, and manufacturing processes by providing accurate and reliable analytical data. Key Responsibilities: Develop, validate, and optimize analytical methods for the analysis of pharmaceutical compounds using techniques such as HPLC, GC, and spectroscopy. Perform routine and non-routine analysis of raw materials, intermediates, and final products to ensure compliance with regulatory standards. Collaborate with R&D, Quality Control, and Manufacturing teams to troubleshoot and resolve analytical challenges. Prepare and review technical reports, method validation protocols, and standard operating procedures (SOPs). Maintain and calibrate analytical instruments, ensuring they are in proper working order. Interpret and present analytical data to support decision-making processes. Stay current with industry trends and advancements in analytical techniques. Preferred candidate profile Bachelor's or Master's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field. A Ph.D. is preferred. Proven experience in analytical method development and validation, preferably in the pharmaceutical or biotechnology industry. Proficiency in using analytical instruments such as HPLC, GC, LC-MS, and spectroscopy. Strong understanding of regulatory requirements (e.g., FDA, ICH guidelines) related to analytical methods. Excellent problem-solving skills and attention to detail. Ability to work independently and as part of a team in a fast-paced environment. Strong written and verbal communication skills. Perks and benefits Opportunity to work on innovative research projects that contribute to groundbreaking therapies. Collaborative and inclusive work environment that values professional growth and development. Competitive salary and benefits package. A chance to make a real impact in the field of pharmaceutical research. How to Apply: Interested candidates are invited to submit their resume and a cover letter outlining their experience and qualifications to business@offtargets.com