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HomeAR&DRubicon Research recruitment | Job openings for R&D, AR&D, Formulation Development, Lab...

Rubicon Research recruitment | Job openings for R&D, AR&D, Formulation Development, Lab QA, Analytical Method Validation, Regulatory Affairs

Rubicon Research is a specialty pharmaceutical company that is driven by intellectual property (IP). Our primary goal is to offer cost-effective and groundbreaking patient-centered products and solutions to meet the unmet needs globally. We utilize our exclusive technologies and expertise in formulation development to overcome intricate delivery obstacles, ultimately leading to improved patient outcomes.

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Greetings from Rubicon Research!

We are hiring various positions in R&D, AR&D, Formulation Development, Lab QA, Analytical Method Validation, Regulatory Affairs.

  1. Officer – Formulation Development ( R & D ) – Pharma – Thane
  2. Officer – Analytical Research & Development – E & L – Pharma – Thane
  3. Executive/ Senior Executive Lab QA – Ambernath
  4. Executive/ Sr Executive- Regulatory Affairs ( US, EU )- Pharma – Thane
  5. Sr. Officer – Analytical Method Validation – Pharma – Thane
  6. Senior Executive – Formulation Development ( R & D ) – Pharma – Thane.

Officer – Formulation Development ( R & D ) – Pharma – Thane

Experience: Minimum Masters Degree in Pharmaceutical sciences educational background with 1-3 years of experience in the regulated market (US / Europe).

Job description

  • Dosage Form – Injectables, solid dosage products (tablets, capsules), and other delivery forms (e.g. liquids, powders).
  • Responsible for the development of new products and optimization of existing formulas; product lines including traditional Injectables, solid dosage products (tablets, capsules), and other delivery forms (e.g. liquids, powders).
  • Responsible for formulation and process development of Injectables, and oral dosage forms, including oral solid and liquid formulations. Troubleshoot and problem-solve unresolved or new formula issues.
  • Design and execute formulation trials and evaluate stability data to finalize formulation composition.
  • Develop robust manufacturing processes for R&D formulations so that the technical transfer is successful for large-scale batches.
  • Knowledge of regulatory guidance.

Contact Person –

Pranali

HR Department

pranali.bate@rubicon.co.in

Officer – Analytical Research & Development – E & L – Pharma – Thane

Experience: 2 – 5 years

Qualification: M.Sc in chemistry, M.Pharm Analysis, with experience of operating LC-MS of any make.

Job description

  • To perform the method development, routine analysis, validations of E&L, nitrosamines, and other applicable tests by LC-MS
  • Planning and execution of method development, Perform routine, stability analysis, and Validation activities on LC-MS E&L, nitrosamines, and other applicable tests by LC-MS.
  • Provide inputs and observations during analysis to identify root cause of failure and OOT data.
  • Preparation and review of AMDRs
  • Adherence to GLP and compliance
  • Preparation and review of risk assessment reports for Extractables
  • Possess basic knowledge of chromatography, and mass spectrometry.
  • Sound knowledge of method development by chromatography
  • Developing and interpretation of mass spectra
  • Aware ICH guidelines Q1 stability, Q2 Validations, Q3 Impurities, M7, PQRI, USP general chapters on Extractables and Leachables, Nitrosamines guidelines of USFDA, EMA.

Contact Person:

Pranali

HR Department

pranali.bate@rubicon.co.in

Executive/ Senior Executive Lab QA – Ambernath

Experience: 7 – 10 years

Role & responsibilities

1) Well versed in the analytical review of documents, which includes of those from GLP section, OOS, OOT, Events, Column management, Standard handling, pharmacopeia, retention samples, stability management & review of stability protocol/summary sheet, computer system validation, calibration & qualification of instruments.

2) Review of audit trail from the computerized systems.

3) Ensure QC laboratory compliance at all times.

4) Preparation & review of OOS/OOT/Events trending.

5) Review of analytical documents, chromatograms, AMT/AMV protocols and reports.

6) Review of specification & STP.

7) Preparation of SOPs

7) To review the Analytical reports in support of Batch release activities

8) To review and approve the batches with generation of Certificate of Analysis for Finished Product

10) Review Analyst qualification data

11) Monitor control sample management.

12) Check rounds of lab and participate in internal audits

13) Leading the group independently in the absence of Manager and planning the activities

Preferred candidate profile:

Candidate should have good experience in Lab QA, Method validation, Method transfers Qualification of instruments CSV with 21CFR part 11.

Interested candidates may apply on Madhura.patil@rubicon.co.in

Executive/ Sr Executive- Regulatory Affairs ( US, EU )- Pharma – Thane

Experience: 4 – 8 years

Job description

Regulatory Affairs- ANDA, NDA and Post Approval Preparation, Compilation and Submission, Review of Labeling, Annual Report and PADER Submission.

  • Review labelling and SPL (Summary of Product Characteristics) for submissions.
  • Prepare, review, and submit pre- and post-approval submissions for pharmaceutical products in the US, EU markets.
  • Compile, review, and publish eCTD dossiers for USFDA-ANDA/EU-MAA applications, as well as other regulatory submissions.
  • Work with stakeholders to gather the required data and information for Submission.
  • Review specifications, batch manufacturing, process validation, method validation, and analytical documents for submissions.
  • Manage the process of receiving and responding to deficiencies from regulatory authorities.

Must-Have Skills:

1. USFDA Experience

2. Handled ANDA /NDA Submissions

3. B. Pharma/ M. Pharma

Contact Person –

Pranali

HR Department

pranali.bate@rubicon.co.in

Sr. Officer – Analytical Method Validation – Pharma – Thane

Experience: 2 – 7 years

Required Profile:

  • M. Pharm/M. Sc (Organic or Analytical chemistry)
  • Instrument Knowledge of handling HPLC, GC, KF, IC, Auto titrator, Advance mass technique etc.
  • Exposure US, UK, EU, ROW regulatory bodies
  • Exposure to GDP to meet the regulatory requirement.

Job description

  • The candidate shall have the role of Senior Officer in the analytical method validation team (AMV) to execute the method validation activity for the finished product and API analysis with good documentation for different regulatory markets.
  • To perform analytical work for validation, verification, and method transfer of finished products and API.
  • Responsible for preparation and reports for method validation/method verification.
  • Responsible for preparation protocols and reports for analytical method transfer.
  • Responsible for initiation, execution & approval of all incidences, investigations, Change Control, Deviations, CAPA, etc.
  • Responsible for coordinating with Analytical development team members in case of discrepancies observed during validation/verification/transfer.
  • Responsible for calibration of instruments like HPLC, GC, pH meter, and analytical balances.
  • To ensure that the analytical work carried out by team is in compliance to GLP, regulatory and quality expectations and is audit ready to ensure standard of GLP to meet FDA expectation.

Contact Person:

Pranali

pranali.bate@rubicon.co.in

HR Department

Senior Executive – Formulation Development ( R & D ) – Pharma – Thane.

Experience: 4 – 8 years

Required Profile:

  • Minimum Masters Degree in Pharmaceutical sciences with 2+ years relevant experience.
  • Candidate should have hands-on/practical experience in development, technology transfer, and ANDA submissions for solid/ liquid oral dosage forms (solutions, suspensions, tablets, capsules) for regulated and semi-regulated markets like the US, Europe, and ROW.

Job description

  • Responsible for the development of new products and optimization of existing formulas; product lines including solid dosage products (tablets, capsules) and other delivery forms (eg, liquids, powders) for regulated markets like US, Europe and ROW.
  • Responsible for formulation and process development of oral dosage forms, including oral solid and liquid formulations. Troubleshooting and problem-solving of unresolved or new formula issues.
  • Design and execute formulation trials and evaluate stability data to finalize formulation composition.
  • Develop manufacturing processes for R&D formulations so that the technical transfer is successful for large-scale batches.
  • Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports, QOS, etc.
  • Works with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control, etc. to expedite the development and approval of new products by the FDA.

Contact Person:

Pranali

HR Department

pranali.bate@rubicon.co.in

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