Exp: 2- 6 yrs • Knowledge in Method Development on Assay, RS, dissolution for formulation complex molecules. • understanding of Q1/Q2 evaluation • PEQ processes and characterization • Instruments: HPLC, GC, KF, UV, IR, etc. pranathi.p@orbicular.co.in
We are hiring! We’re seeking a skilled Business Development Professional to lead out-licensing efforts for our pharmaceutical pipeline. Business Development – Out-Licensing Location: Hyderabad (Onsite) Reports To: Head of Business Development & Portfolio Experience: 5–8 years in pharma BD/out-licensing. Key Requirements: The role involves identifying global partners, driving licensing strategies, leading deal negotiations, and collaborating with cross-functional teams. Strong grasp of drug development, regulatory (US FDA, EMA), and IP Experience with licensing deals in regulated markets (US/EU/Japan) Excellent negotiation, analytical, and stakeholder management skills Master’s degree in pharmacy/Life Sciences (MBA preferred)
You will be responsible for leading the out-licensing efforts for the pharmaceutical pipeline of the company. As a skilled Business Development Professional, your main tasks will include identifying global partners, driving licensing strategies, leading deal negotiations, and collaborating with cross-functional teams. To excel in this role, you should possess a strong grasp of drug development, regulatory requirements such as US FDA, EMA, and intellectual property matters. Experience with licensing deals in regulated markets like the US, EU, and Japan will be highly beneficial. Your key attributes should include excellent negotiation skills, analytical capabilities, and effective stakeholder management. As the ideal candidate, you should hold a Master's degree in Pharmacy or Life Sciences, with an MBA being preferred. This position is based in Hyderabad and will report to the Head of Business Development & Portfolio. With at least 8 years of experience in pharmaceutical business development and out-licensing, you will play a crucial role in expanding the company's global partnerships and driving its growth in the pharmaceutical industry.,
You will be responsible for leading the out-licensing efforts for our pharmaceutical pipeline as a skilled Business Development Professional. The location for this role is Hyderabad (Onsite) and you will report to the Head of Business Development & Portfolio. To be successful in this position, you should have at least 5-8 years of experience in pharma business development and out-licensing. Your main responsibilities will include identifying global partners, driving licensing strategies, leading deal negotiations, and collaborating with cross-functional teams. It is essential to have a strong understanding of drug development, regulatory processes (such as US FDA, EMA), and intellectual property rights. Experience with licensing deals in regulated markets such as US, EU, and Japan will be highly beneficial. In addition, you should possess excellent negotiation skills, analytical abilities, and stakeholder management skills to excel in this role. A Master's degree in pharmacy or Life Sciences is required for this position, with an MBA being preferred.,
Were seeking a skilled Business Development Professional to lead out-licensing efforts for our pharmaceutical pipeline. Qualification : MBA/M.Pharm with PMP preferrable Experience : Min 10Years Designation : Dy.Mgr/Mgr/Sr.Mgr Department : Project Management Role & responsibilities : Manage all day-to-day project-related activities throughout the project life cycle, from initiation to approval and closure. Plan, execute, coordinate, and close all project activities as per the committed timelines. Ensure smooth execution of projects from the PIF (Product Information Form) stage to Exhibit batch completion, stability loading, pivotal BE studies, filing, and commercial approval. Develop and implement project management processes and tools to track and control projects effectively. Coordinate with different manufacturing units to ensure exhibit batches are completed as per the committed timelines. Handle customer projects as the primary point of contact, ensuring adherence to project management processes from initiation to closure. Assess, finalize, and track project budgets in collaboration with the Project Leader. Collaborate with CFTs and coordinate activities to ensure timely closure of project tasks. Coordinate with Supply Chain Management to plan and ensure timely availability of resources. Regularly review project progress with project leaders from R&D, Plant, and customers on a weekly/fortnightly basis. Prepare and provide project status reports to management, ensuring clear communication of milestones and deliverables. Actively manage, schedule, and participate in meetings (face-to-face, teleconferences, and video calls), capturing the minutes and following up on action items. Conduct weekly and monthly review meetings with CFTs to monitor project progress. Present project progress, including milestone achievements and exhibit batch completion, to management on a monthly basis. Track all projects and maintain timelines using project management tools (PPM). Ensure all assigned projects are completed ahead of schedule while maintaining strict adherence to quality standards, leading to customer appreciation. Oversee site transfer projects and ensure completion within the defined timeframe. Review project risks and resolve issues proactively to ensure project success. Provide reports and updates as required by management, ensuring project activities are aligned with business objectives. Skills & Qualifications: 8 to 10 years of experience in project management within the pharmaceutical industry. Proficiency in project management methodologies and tools. Familiarity with pharmaceutical regulations, quality assurance, and compliance standards for complex/ophthalmic/nasal product development. Ability to anticipate and mitigate project risks, resolve issues promptly, and make data-driven decisions. Preferred Qualifications: PMP or other relevant project management certification. Experience in managing projects across multiple geographical locations or manufacturing units.
Were seeking a skilled Business Development Professional to lead out-licensing efforts for our pharmaceutical pipeline. Location: Hyderabad (Onsite) Reports To: Head of Business Development & Portfolio Experience: 5+ years in pharma BD/out-licensing. Role & responsibilities : The role involves identifying global partners, driving licensing strategies, leading deal negotiations, and collaborating with cross-functional teams. Strong grasp of drug development, regulatory (US FDA, EMA), and IP Experience with licensing deals in regulated markets (US/EU/Japan) Excellent negotiation, analytical, and stakeholder management skills Masters degree in pharmacy/Life Sciences (MBA preferred)
Dear Candidate, We are looking for formulation scientists for our Ophthalmic and Nasal teams in Formulations, focusing on the formulation development of sterile ophthalmic dosage forms solutions, suspensions, and emulsions. This role involves complete ownership of formulation and process development with a strong emphasis on regulatory compliance and timely execution. Position1: Assistant Manager Department: Ophthalmic team - Formulation Development Required Exp : 8-12years Position2: Research Associate/Sr.Research Associate Department: Nasal team - Formulation Development Required Exp: 4-8years(Candidates from injectables background can also apply.) Role & Responsibilities: Formulation & Process Development Independently develop formulations for ophthalmic, injectables and nasal sprays Design and interpret DoE studies for optimization and robustness Technology & Excipient Evaluation Select excipients, containers/closures, and delivery systems (BFS, vials, spray pumps) Conduct risk assessments for compatibility, leachables, and functionality QbD & Risk Mitigation Define QTPP, CQA, and CPPs Apply DoE-based approaches for robust formulation and process design Scale-up & Technology Transfer Design scalable processes and identify critical material and process attributes Support scale-up, exhibit, and validation batches (in-house/CMO) Regulatory Documentation Prepare 3.2.P.2 / 3.2.P.3 sections, development reports, and risk assessments Address regulatory queries and support ANDA / 505(b)(2) filings DeviceDrug Integration Oversee device evaluations (spray pattern, plume, PSD, E&L) Ensure alignment between formulation and device requirements Cross-functional Collaboration Work closely with ARD, QA, RA, SCM, device, and manufacturing teams Coordinate packaging/device-related studies and tech transfer activities Project & Team Management Lead development of complex sterile products Mentor junior team members and ensure GLP/documentation compliance Drive timelines in alignment with CMC and regulatory milestones Required Skills and Qualifications: M.Pharm (Pharmaceutics) Strong understanding of formulation science, aseptic processing, and regulatory pathways (USFDA and other markets) Hands-on experience with E&L studies, ICH Q3D, and risk-based development Proven problem-solving skills and scale-up troubleshooting Experience with CMO/CRO coordination and technology transfer Benefits: 5day week, Canteen/Bus facility, Mediclaim, accidental benefits..etc. Suitable and Interested candidates can share their profiles along with basic details curr.org., total exp, Curr.Location, CTC,Expected CTC, Notice period..etc Mail ID: kiran.k@orbicular.co.in / pranathi.p@orbicular.co.in Ph.No 9000251866 Regards Team HR.