Jobs in Biocon

1. Designation: Manager - Projects and EngineeringNo. of Positions: 1Department:  Projects & EngineeringExperience: 7-9 yrsQualification: B E (MECH with Specialization in Air Conditioning) (Preferably from IIT/or an Institute of Repute).

Role/Job Description: 

Concept design of HVAC System for Classified, unclassified and Ventilation areas for Various API, Formulation and Lab Projects. Design and detailing of various HVAC requirements. Provides support for the Preparation of URS, FDS, DQ, IQ, OQ and start-up of the facility. Participate in FATs, SATs, Commissioning and Validation efforts. Participates in site discussions, measurements to ensure that quality and specifications of design are met. Reports to Sr Manager - Projects.
Technical / Functional Skills

• Develops HVAC and Clean Room Concept design
• Develops Area, Pressure and Classification zoning
• Validates the design and Concept with QA for regulatory requirements
• Captures requirements of the process and safety
• Determines operating, min and max conditions
• Prepare detailed Room data sheet for Heat Load calculations
• Design and Prepare optimal heat loads
• Design low side equipments like AHU (classified and Unclassified), Dehumidifiers and all type of air handling equipments
• Design High side equipments like Chiller, Cooling Towers and Pumping systems
• Prepares Low side BOQ  
• Prepares and Participates in Techno Commercial Comparison and discussions
• Should strive for design, equipment and performance improvement

Additional Notes/Information:

• Specific experience in the area of Clean utilities like Purified water, WFI and Pure Steam would be an added advantage

2. Designation:  Senior Scientist - Process development cell culture-R&D

No Of positions: 1 Education Qualification: M.Tech or PhD in Engineering (preferably Biochemical engineering/Chemical engineering) / M.Sc candidates Experience: 3-6 Years (Industrial experience)

Job Description:

• The ideal candidate should have hands-on experience in development of stirred tank processes in a leading biopharmaceutical company in the late stage mammalian cell culture development facility or a pilot plant.
• The candidate should have experience in design, development, scale-up and troubleshooting of cell culture process from laboratory bioreactors to pilot or production tanks. 
• Ability to work with scientists in a laboratory as well as in a production set-up would be useful. 
• Experience in the resolution of technical problems during manufacturing would be an added advantage.
• Understanding of regulatory compliance and guidelines e.g. FDA and EMEA desirable.

Technical / Functional Skills

• The candidate should have lead a group of scientists in the past.
• Good verbal and written skills are needed.
• Extensive skill, knowledge, and experience are needed for this position.
• Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
• Use logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems

3. Designation:  Scientist / Sr. Scientist - RND - ANF 

No Of positions: 1 Education Qualification: M.Pharm/M.tech Experience: 1-4 years

Job Description:

• Conducting analytical characterization
• Pre-formulation studies and indicative stability programs of biologicals
• Coordinating activities between the formulation group and purification/quality control groups

4. Designation:  Sr. Manager - Phamacovigilance

No Of positions: 1 Education Qualification: MD-Pharmacology with 6-10 yrs of experience in phamacovigilance or M.Pharm /PHD with relevant work experience.Experience: 6-10 YearsIndustry Type: Biopharmaceuticals/ Pharmaceuticals/Chemical / Biotech/Clinical Research /APIFunctional Area: Phamacovigilance

Job Description:

The incumbent should provide global drug safety and phamacovigilance surveillance for marketed and investigational products. S(he) should provide case management and maintain phamacovigilance and drug safety operations. S(he) should conduct medical assessment, determine additional information needed and independently generate drug safety. S(he) will be responsible for drug safety crisis management. S(he) will overlook the signal detection and risk management activities for designated global products. S(he) should design and implement systems for drug safety collection, processing, reporting and coding. S(he) will be involved in making strategies for pre and post marketing risk management and should keep abreast of phamacovigilance methods and trends in published literature and global regulation. The position will be in the quality department and the incumbent will report to the head of quality.

Technical / Functional Skills

• MD-Pharmacology with 6-10 yrs of experience in phamacovigilance or M.Pharm /PHD with relevant work experience.
• Experience in contract research organization or pharmaceutical / Biotechnology Company is a must.
• In-depth clinical background is needed. Should have good knowledge of EMEA, Non-EU and FDA regulation.
• Should have strong knowledge of worldwide safety regulation for marketed and investigational products.
• Should have industrial knowledge experience in drug safety and phamacovigilance and FDA and global regulations related to drug safety reporting ,ICH guidelines, and GCP and the process required to comply.

Behavioral / Management / Other Skills:

• Should have excellent oral and written communication skills. Should be able to present/articulate to large internal/external groups
• Should have very strong judgment; and exhibit tactful discretion.
• Should have analytical thinking and problem solving skills.
• Should be able to make high level decisions.
• Should be able to build a team in a short span of time.

Location: Bengaluru /Bangalore

5. Department: Production

Position: Jr. ExecutiveQualification: B.Sc - Any Specialization, Bio-Chemistry, Chemistry; Diploma - Any Specialization, Chemical.Experience: 0 - 2 Years.Location: BangaloreJob Description:

• Handle the day to day activities of the production
• Handle day to day cell culture and purification activities in departments

Candidate Profile:

• The ideal candidate should be a diploma in chemical or petro-chemical engineering or BSc with chemistry, biochemistry with 1 to 2 years experience
• Should able to handle trouble shoot operations and function as a part of the team
• Should able handle the day to day activities of the production
• Male candidates preferred as this job involves night shifts

6. Department: Production

Position: ExecutiveQualification:B.Tech/B.E.- Any Specialization, M.Sc - ChemistryExperience: 2 - 4 Years.Location: BangaloreJob Description:

• Monitoring of daily Production activities
• Streamlining of documentation and operations

Candidate Profile:

• Should have manpower management capabilities and effective communicational abilities
• Should have the qualification or B.Tech of MSc chemistry with 1 to 2 years of relevant experience
• Should able handle the day to day activities of the production
• Male candidates preferred as this job involves material handling and night shifts

7. Position: Toxicology

Location: BangaloreQualifications:

• Hands-on experience in designing and directing GLP tox and/or safety pharmacology studies involving protein and/or small molecule drug candidate.
• Ph.D. with 4+ years in toxicology preferably from industry.
• Knowledge and experience in regulatory submission is highly desirable
• Self-motivated, attention to detail, dedication to quality, and willingness to learn
• Ability to work independently and interdependently in a supportive multi-functional team setting.
• Working knowledge of GLP regulations
• Demonstrated in vivo experience
• Highly developed medical writing skills

Responsibilities

• Design, conduct and carry out preclinical safety/toxicology and other preclinical studies
• Coordinate, supervise, and manage contract GLP toxicology and safety pharmacology studies
• Responsible for protocol generation, initial selection and negotiation with CROs, study monitoring, data collection and analysis, and report writing/drafting
• Assist preparation of preclinical portion of regulatory submissions such CTD, BLA and IND.
• carrying out risk assessments on potential new drugs to see they are safe to test on humans;
• assessing whether the benefits of the drug outweigh the risks;
• carrying out work on cells and tissues before tests are carried out on animals and then humans.

8. Department: API Marketing

Position: Deputy Manager/Manager Qualification: Bsc/B.Pharm + MBAExperience: 5-8 YearsLocation: BangaloreJob Description:

• Market Survey, Market Research & Development for A.P.Is and Intermediates in Domestic as well as on International Level
• New product development.
• Managing International and Domestic business.
• Product Registration and approval of products in various countries.
• MIS Management.

Desired Profile:

• Marketing and Sales Professional with over 6 years Marketing and Sales experience in A.P.Is (Active Pharmaceutical Ingredients), Intermediates and Specialty Chemicals.
• Exceptional Communicator with consultative sales style, strong negotiation skills, exceptional problem solving abilities and a keen customer needs assessment aptitude.

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