Current Openings

Analytical R&D : Scientist

Job description :

  • Performing analytical method validation/ raw material/ finished product analysis/
  • Performing assay by using HPLC
  • To perform analysis related to Method Transfer and Analytical Method Verification
  • Preparing method validation protocols & reporting.

Required Candidate profile:

  • Education : M.Sc / M. Pharma / Ph.D
  • Experience : 2 - 8 years
  • Position : Research Associate to Research Scientist
  • Location : Hyderabad
  • Industry Type : Pharmaceutical
  • Functional Area : R&D, Pharmaceuticals
  • Employment Type: Full Time

Formulation R&D Scientist : Pharma

Job description :

  • R&D Scientist - Formulation Scientist
  • Pharmaceuticals/ Biotechnology/ Clinical Research

Required Candidate profile:

  • Education : - Doctorate / Masters in Pharmaceutics, Pharmaceutical Chemistry, Industrial Pharmacy, Analytical Chemistry, Pharmaceutical Chemistry, Organic Chemistry or Medicinal Chemistry.
  • Experience : 5 - 10 Years
  • Domain : Pharmaceuticals
  • Location : Hyderabad

EXPERIENCE :

  • In-depth understanding of physical pharmacy, physical chemistry, thermodynamics, chemical reaction kinetics is a must.
  • In-depth understanding of various pre- formulation and formulation studies including excipient compatibility, forced degradation studies and unit steps in formulation manufacture is a must.
  • Experience with pilot-scale and manufacturing-scale equipment is a plus.
  • Experience with process analytical technologies (PAT) is a plus.
  • Conduct API, excipient, packaging or device characterization; excipient compatibility and forced degradation studies.
  • Develop robust lab-scale, pilot-scale and commercial-scale manufacturing process based on Quality by Design (QbD) principles using design of experiments (DOE). Recommend stage appropriate acceptance criteria. Utilize PAT where feasible. Utilize relevant statistical tools, as required.
  • Review and analyze relevant stability data from lab-scale, pilot-scale and commercial-scale, R&D and GMP stability studies by utilizing industry standard modeling and analysis tools including regression analysis for shelf-life prediction. Develop and implement strategies to control related substances, where applicable.
  • Draft high-quality industry standard technical documents (protocols, reports, technical memorandums, position papers etc.).
  • Independently draft and/or review standard operating procedures (SOPs).
  • Maintain effective and pro-active communication and coordination of activities with multi-functional stakeholders.

SCIENTIST - Medicinal Chemistry

Cellix Bio is hiring Scientists for Medicinal Chemistry department.

Education and experience required: M.Sc (Organic/ General/ Industrial Chemistry) with 5-7 years of experience in drug discovery in medicinal chemistry.

Capable of handling milligram to multigram scale reactions and doing multi step synthesis.

Key Responsibilities:

  • Plan the synthetic routes for the targeted compounds.
  • Perform literature search using scientific database (SciFinder etc.)
  • Perform different chemical reactions for the small and medium scale synthesis of compounds following good laboratory practices.
  • Analyzing compounds using a good range of modern separation and spectroscopic techniques.
  • Interpret and characterize the products and compile data for every experiment
  • Write and maintain records of observations and conclusions for every experiment in timely manner
  • Conducting literature searches for specific target compounds, structures related to the target compound and determine specific conditions for reactions.
  • Communicate experimental outcome and provide routine updates to the reporting manager on status of the work plan
  • Writing scientific procedures, presentation of research summaries at project meeting.
  • Active participation in departmental seminars
  • Follow safety protocols and maintain the lab in a clean manner

SENIOR RESEARCH ASSOCIATE – Medicinal Chemistry

Cellix Bio is hiring SRAs for Medicinal Chemistry department.

Education and experience required: M.Sc (Organic/ General/ Industrial Chemistry) with 4 to 5 years of experience in drug discovery in medicinal chemistry.

Key Responsibilities:

  • Multi-step synthesis.
  • Scaling up of the reactions from mg to gm scale.
  • Characterization of a compound using LCMS, NMR and purity by HPLC.

Technical/Functional Skills: Sound knowledge on organic chemistry and scale up reactions from mg to gm scale.

TEAM LEADER - Medicinal Chemistry

Cellix Bio is hiring Team Leaders for Medicinal Chemistry department.

Education and experience required: M.Sc (Organic/ General/ Industrial Chemistry) with 8 - 10 years of experience in drug discovery in medicinal chemistry.

Job description:

  • PhD in Organic Chemistry with ~10 years of Post-Doctoral (academic/industrial) research experience.
  • Publications in peer-reviewed journals.
  • Experience in people management and ability to lead a team of 15-20 scientists.
  • Experience in Medicinal Chemistry, Drug Discovery or Integrated drug discovery projects.
  • Good understanding and grounding in synthesis of complex target molecules for the purpose of biological screening.
  • Supporting the Business development activity as and when it is needed.
  • Interaction with different stakeholders (internal and external).
  • Analyzing, interpreting and presenting the scientific data at different forums.
  • Candidate should have hands on experience in CRO projects and coordinate with cross functional teams like analytical/SCM/Biology.
  • Participating in recruitment and mentoring new hires.
  • Understanding of systems and process pertaining to safety, health and environment. Follow the EHS guidelines as per zero tolerance policy. Participate in various EHS-related activities in educating team members and in maintaining high safety standards

PROJECT MANAGER (Pharma/strategic/agency experience)

We are currently seeking a Project Manager to oversee the delivery of high-level advisory meetings in a broad spectrum of therapeutic areas. As a Project Manager, you will work as part of a project team, including clients and healthcare experts, to develop customized, in-person and web-based advisory board meetings in the US and India.

Purpose of Role : The Project Manager manages multiple aspects of projects to ensure that all projects are delivered on time and within scope and budget. This position requires a professional level of communication with clients and healthcare experts.

Essential Duties and Responsibilities: Assist Senior Managers, Directors and Consultants with the planning and documentation related to recruiting thought-leaders and providing effective communications, including but not limited to:

Developing and updating spreadsheets and communications. Performing Internet research. Responsible for quality data management. Manage project plans, timelines, and out-of-pocket budgets. Coordinate and schedule meetings with internal team, clients, and thought-leaders. Develop accurate documents and communications for use with CROs. Supports senior project staff with larger and more complex projects. Assists senior project staff on-site, where Project Manager will act as a point-of-contact and coordinator for clients and/or thought-leaders;

Bachelor’s Degree in Communications, Business, Marketing, or another related Health-care field. Minimum 2–5 years of experience in pharmaceutical or health-care industry. Strong project management and communications experience.

SENIOR MANAGER, Pre-Clinical

To direct investigative safety studies that support de-risking of innovative drug targets and modalities, non-clinical compound candidate selection. Develop strategy for bringing in state of the art techniques, and apply them to prospective and retrospective in vivo, ex vivo and in vitro evaluations of drug safety, with a particular emphasis on comparative biology of innovative therapeutic targets, pathways and modalities. Nonclinical investigative safety assessment plan to support development/registration of drugs of various and novel modalities.

PhD in pharmacology, toxicology, immunology, molecular biology, biochemistry, cell biology or a related biological science; MD, DVM, PharmD with at least 5 years of experience in the related field. Demonstrated leadership in cross-industry organization. An understanding of the drug development process and how investigative science plays a role in quickly and efficiently addressing key questions.

REGULATORY AFFAIRS: Associate Director, CMC & Analytical Services

Responsible for management analytical services and Chemistry, Manufacturing and Controls (CMC) function including, the development and maintenance of analytical and CMC related Quality Systems, identification, development and maintenance of contract labs, analytical method development/validation/transfer, Quality Assurance oversight of OOS investigations, analytical data review for raw materials, in-process materials and Finished Goods lot release testing, management of the stability program, and development. CMC Expert providing strategic direction and support to on-site manufacturing, Operations, R&D, Clinical and Commercial teams developing and commercializing products approved via NDA and PMA pathways.

Expert knowledge of cGMP for finished pharmaceuticals. MSc / PhD in chemistry or chemical engineering with 5 – 10 years of experience.

REGULATORY AFFAIRS, Associate

The candidate will be expected to prepare and review many types of documents for submission to the FDA, including the following (not an all-inclusive list), in a format compliant with FDA standards. In addition, the candidate will be expected to communicate with FDA and represent the Regulatory Affairs department in cross functional team meetings and must possess a strong understanding of regulations and guidances. The applicant will assist in determining regulatory strategy for new submissions and post-approval changes.

The ideal candidate must have experience with thoroughly reviewing documentation required for 505(b)(2) submissions for accuracy and completeness, and successfully communicating with FDA and other stakeholders (internal and external). The candidate must have the ability to work independently and manage/prioritize projects to ensure targeted timelines are met.

A minimum of 2 years’ experience in Regulatory Affairs with a Bachelor’s / Master’s degree, preferably in Chemistry or a related, scientific discipline. Experience with Adobe Acrobat and Windows-based programs such as Microsoft Word, Excel, and SharePoint is required.

PATENT ASSOCIATE, Chemistry / Pharma

Conducting patent & non-patent literature searches including prior art, freedom to operate, invalidation and other searches. Providing insightful analysis of search results from various sources by preparing and delivering timely, value-added patent search reports based on in-house established patent search protocols. Drafting Provisional and Complete Specifications for patent applications. Attending to Examination reports and Office Actions by giving technical arguments (written & verbal) and attending hearings at the Indian Patent Office (in case of registered patent agents).

Postgraduate/Doctorate in Pharma/Chemistry with good academic record. In-depth knowledge of IPR or two years of experience in IPR. Preference will be given to registered patent agents. Minimum 3 years of experience in the field of IPR for the Group Leader position.