דרושים Analytical Researcher ב-טבע ב-הודו

• To perform the method transfer and method validation of microbiology samples for drug substances and finished products.
• Sound knowledge of Microbiology andMicrobiological testing of various products like in-process, finished products, Drug substances, excipient and stability samples etc.

• Shall have FDA approval in Microbiology
• To ensure the Initiation of the microbial method validation for the drug substances , excipient and finished products.
• To ensure submission of the microbial method validation summary report to Regulatory department.
• Preparation and updation of STP and analytical related SOPs.
• Regulated market experience (US/EU/Canada etc)
• Ensure the microbial methods for all the products are in place and testing is performed as per validated method.
• To ensure microbial culture media/ bioballs and other accessories availability in timely manner to have smooth operations in the lab.
• Review of the study protocols and Summary reports.
• To ensure timely testing and release of Water, Compressed Air, Stability Samples as per schedule and Raw material, Finished product as per production requirement.
• Reporting, investigation and close out of safety incidents encountered in the laboratory during Gemba rounds
• To ensure timely completion of all microbiology investigation investigation and close out as per due date.
• Active participation in regulatory Inspections, customer Inspection and Inspection observation compliance.
• To monitor activities in the laboratory as per Data Integrity requirements.
• To ensure timely revision of Standard Test Procedure and Standard Operating Procedures on need basis due to facility change or in line with Teva CORP Standards.
• To ensure upkeep and monitor all microbiology samples.
• Any other activity assigned by the line manager

• B.Sc. Microbiology with 5 to 11 Years of experience
• MSc. Microbiology with 4 to 9 Years of experience

Group Leader Quality Control

• Bench scientist with good analytical acumen in the area of formulation research and development, process development, Regulatory and Intellectual property for global markets.
• Planning and conducting of experimentation in line with project milestones.
• Should have worked on products at different stages from selection to launch with scientific principles of QbD, DoE, statistics and scaleup principles.
• Ability to comprehend facts and data from literature reviewed and present the information effectively for decision making.
• Understand IP scenario and work on various design around strategies, search prior art, and experimentally establish the proof of concept.
• Help identify the challenges associated, bottle necks in development and suggest mitigation proposals during development at various stages.
• Co-ordinate with CFTs viz. MS&T, QA, QC and production at different geographies for technology transfer and timely execution of submission batch(es).
• Problem solving- identify problem statement, gather facts and to facilitate analysis formulation development, process issues.
• Priortize activities with leads for experimentation in lab. Participate in execution of development trials and during execution of submission batches and further during commercialization.
• Align day to day activities in line with established milestones, execution of batches at global TGO operation site.
• Clear comminications with internal stakeholders, for identfying challenges/risk areas which would hamper the timely delivery of products.
• Align with the BU KPIs and work with group leaders/ leadership teams for implementation of organizational initiatives.
• Assist the domain leader in business process evalaution and identifying improvement areas.
• Demonstrate personal accountability and effective work habits, viz. working productively & act responsibly, and learn from mistakes.

• Work on bench with the formulation development teams for the timely achievement of key milestones.
• Planning and conducting of experimentation in line with QbD paradigm, using OFATs and DOE.
• Preparing Presentations during Products development at all stages (Day 0, Development stage, Pilot BE, Scale-up, EB Phase gate, Filling and Launch Phase gate) and discuss/interpret the data
• To conduct literature review, prior art experiment design of the product identified for development.
• Evaluate API & Excipients sources and Innovator product identification, procurement, characterization and reverse engineering.
• Conduct and interpret data from Preformulation studies viz. Compatibility studies, API particle size finalization (malvern/SEM/Raman), API Solubility studies, polymorphic formphase transformation studies, selection of excipients and process as per strategy.
• Conducting and performing the development trial at bench level, problem identification & resolution.
• Review and interpretation of analytical data for further action plan.
• Responsible for execution of Pilot BE batches and interpretation of bio results.
• Responsible for execution of scale-up and exhibit batches at different manufacturing location with coordination of cross functional team and interpretation of Pivotal bio results.
• Identify Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Process Attributes (CPAs) and subsequent use of Design of experimentation (DOE).
• Establish the stability data for development batches in collaboration with the analytical team.
• Master document preparation like MFC, Scale up batch study protocol/ report, sampling plan, stability guidance documents, In-use stability study protocol/ report.
• Co-ordination with various CFT’S like sourcing, Project Management, analytical, Regulatory, Packing, Production, MSAT, DQA and clinical for smooth development of product.
• Compilation and preparation of pharmaceutical development report with respect to current QbD format.
• Responsible for preparation of Product Developmental Report (PDR) for filling.
• Handling of deviations, change control and OOS related to Exhibit batches.
• Preparation, updation of SOPs.
• Maintaining of batch, calibration and other necessary records.
• Subjecting required batches to stability studies.

• Ph.D. in Pharmaceutical Sciences with 1 Yrs +/ M.Pharm in Pharmaceutical Sciences with 3yrs+ from reputed universities
• Experience in working in a high performance teams in known generic space/ organisations with known generic footprint in regulated markets. Viz. US/EU/Canada

Technical skills

• Formulation Development of Solid Oral Dosage forms, exposure from development and submision to regulatory agencies.
• Uses established process, scientific theories and principles to solve problems
• Good learning acumen
• Basic level understanding on recent ICH, regulatory guidelines, IP requirements; understanding of Bioequivalence, GMP, Quality and SOP compliance, GLP etc.

People Skills

• Must be confident, able to work in the team and a good team player
• Stable and calm, Supports functional colleagues
• Has the ability to take comprehend facts and data to help the decision making.
• Shows respect, listens effectively, show caring & be compliant with the core values of TEVA
• Demonstrates timeliness

Inter personal Skills

• Collaborates with team within functionional area and cross functional teams.
• Good technical communication applied applied locally and contributor to local and/or global project teams.
• Delivers technical presentations.
• Ability to work with very little supervision, work with junior staff
• Ability to work independtly on individual products.
• Ability to work with internal and external partners.

The following areas of responsibility are essential to the satisfactory performance of this position by any incumbent, with reasonable accommodation if necessary. Any nonessential functions are assumed to be included in other related duties or assignments.

• Build rapport and relationships by interacting effectively with regional team members and key external contacts (ie, HCP and entire office staff) at all levels, demonstrating the awareness of their needs and responding with the appropriate action
• Provide healthcare product demonstrations, physician detailing, and in-servicing of products to current and potential customers
• Consult with physicians, nurses, and medical office staff to appropriately promote product and provide product and patient education
• Strategically manage and grow relationships with key accounts by tailoring solutions to meet their unique needs, leveraging industry insights to drive product differentiation and achieve sales targets
• Regularly review and analyze all provided sales data in order to create effective territory plans and utilize promotional budget funds
• Maintain a competitive edge by effectively addressing external market challenges while fostering a collaborative environment with internal teams to drive cohesive and successful sales strategies
• Open to working with cross-functional teams to integrate diverse expertise and insights and achieve shared objectives
• Maintain a call average as outlined in the sales plan, defined as face-to-face interactions, with healthcare providers focusing on top target customers
• Take calculated risks and apply a range of traditional and nontraditional problem-solving techniques to solve issues creatively in order to improve performance in geographical assignment
• Adhere to all Teva’s compliance policies and guidelines
• Achieve all sales performance goals, reach objectives, and complete all administrative duties for geographical assignment

Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/Experience

• Bachelor’s degree required, preferably in related field
• At least 1 year of full-time, documented business-to-business sales experience; pharmaceutical sales experience strongly preferred

Skills/Knowledge/Abilities

• Proven record of accomplishments in this specific market toward meeting established objectives
• Demonstrated interpersonal skills, including active listening, empathy, open communication, inclusivity, and openness to feedback
• Well-developed written and oral communication skills
• Ability to interact with HCPs in both face-to-face and virtual environments, and be proficient with technology
• Knowledge of reimbursement, managed care, or marketing preferred
• New product launch experience preferred
• Broad therapeutic area experience particularly in therapeutic area preferred
• Candidate must be able to successfully pass background, motor, and drug screening
• Valid US driver’s license and acceptable driving record required

Full time documented business to business sales experience dependent on level as listed below. Pharmaceutical sales experience preferred. Level of the role will be commensurate to years of experience and performance criteria.

• Sales Specialist : Minimum 1 year
• Executive Sales Specialist : Minimum 7 years

TRAVEL REQUIREMENTS

Regular travel, which may include air travel and weekend or overnight travel

The annual starting salary for this position is between $88,000 – $170,000 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Finished product testing and analytical method development by HPLC, GC, IC, UV etc.
• Analytical method validation and transfers, analysis of API, Finished product R&D samples

• Analysis of Solid oral dosage i.e. Dissolution, Assay, CU, BU and Related substances etc.
• Analysis of samples received from Formulation department (samples include in-process, finished product, pre-formulation study samples and stability samples etc.).
• To carry out analytical method development and method validation, in-process samples and finished products.
• To carry out analytical method transfer activity to QC, Goa.
• Handling and testing of hi-potent compounds/molecules
• Trouble shooting of analytical instruments for difficulties faced during day-to-day operations.
• Calibration and maintenance of analytical instruments. Maintenance includes activities such as Qualification, keeping track of AMC, History, Spares, Usage records etc.
• Literature Search for development of analytical methods.
• To ensure that all activities undertaken are executed in the framework of good laboratory and documentation practices and the existing quality systems are adhered.
• To ensure safe practices are followed during the execution of activities and strict adherence to the EHS systems of the site.

• M.Sc. / M. Pharm./ Ph. D
• 3-8 Years relevant experience
• Sound knowledge of Chemistry and analytical method development, method validation and transfer, Instrumental method of analysis and logical approach.
• Hands on experience on Instruments viz., GC, HPLC, Ion Chromatography, UV and Dissolution apparatus etc.
• Knowledge of regulatory requirements for different markets (US, EU, Canada etc.
• Knowledge on ICH guidelines, forced degradation studies, impurity profile etc.

• Basic communication skills
• Must be honest and trustworthy
• Be respectful
• Possess cultural awareness and sensitivity
• Outgoing, personable, responsible, self-motivated and confident

• Excellent communication and with hands on experience.

• Having working experience of analytical method development/ validation for HPLC/GC test methods, from different markets.

• Troubleshooting/OOS investigations during validations.

• Having a good knowledge of HPLC, IR, UV, KF Titrator, Halogen Moisture analyzer, Polarimeter and wet analysis

• Having good knowledge of HPLC trouble shooting.

• Sound knowledge of Organic Chemistry & Spectroscopy.

• Having a good knowledge of HPLC Method development of API/RM/KSM and SM using various detector like Mass, IR, CAD, ELSD, UV-PDA and UV.

• Structure elucidation and Identification and characterization of APIs, known and unknown impurities

• and intermediates by various spectroscopy techniques.

• Data interpretation by NMR, Mass Spectrometer, DSC, TGA & FTIR

• Having a sound knowledge of Analytical method validation.

• Hands on experience of various Analytical Instruments-Coulometer, FT-IR, UV, Karl Fisher, Halogen Moisture Analyzer etc., >sound knowledge of Organic Chemistry & Spectroscopy.

• MSc (Organic chemistry/Analytical chemistry)

• 4- 7 years

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

• Bench scientist with good analytical acumen in the area of formulation research and development, process development, Regulatory and Intellectual property for global markets.
• Planning and conducting of experimentation in line with QbD paradigm, using OFATs and DOE.
• Should have worked on products at different stages from selection to launch with scientific principles of QbD, DoE, statistics and scaleup principles.
• Ability to comprehend facts and data from literature reviewed and present the information effectively for decision making.
• Understand IP scenario and work on various design around strategies, search prior art, and experimentaly establish the proof of concept.
• Help identify the challenges assocaited, bottle necks in development and suggest mitigation proposals during development at various stages.
• Co-ordinate with CFTs viz. MS&T, QA, QC and production at different geographies for technology transfer and timely execution of submission batch(es).
• Problem solving- identify problem statement, gather facts and to facilitate analysis formulation development, process issues.
• Priortize activities with leads for experimentation in lab. Participate in execution of development trials and during execution of submission batches and further during commercialization.
• Align day to day activities in line with established milestones, execution of batches at global TGO operation site.
• Clear comminications with internal stakeholders, for identfying challenges/risk areas which would hamper the timely delivery of products.
• Align with the BU KPIs and work with group leaders/ leadership teams for implementation of organizational initiatives.
• Assist the domain leader in business process evalaution and identifying improvement areas.
• Demonstrate personal accountability and effective work habits, viz. working productively & act responsibly, and learn from mistakes.

• Work on bench with the formulation development teams for the timely achievement of key milestones.
• Planning and conducting of experimentation in line with QbD paradigm, using OFATs and DOE.
• Preparing Presentations during Products development at all stages (Day 0, Development stage, Pilot BE, Scale-up, EB Phase gate, Filling and Launch Phase gate) and discuss/interpret the data
• To conduct literature review, prior art experiment design of the product identified for development.
• Evaluate API & Excipients sources and Innovator product identification, procurement, characterization and reverse engineering.
• Conduct and interpret data from Preformulation studies viz. Compatibility studies, API particle size finalization (malvern/SEM/Raman), API Solubility studies, polymorphic formphase transformation studies, selection of excipients and process as per strategy.
• Conducting and performing the development trial at bench level, problem identification & resolution.
• Review and interpretation of analytical data for further action plan.
• Responsible for execution of Pilot BE batches and interpretation of bio results.
• Responsible for execution of scale-up and exhibit batches at different manufacturing location with coordination of cross functional team and interpretation of Pivotal bio results.
• Identify Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Process Attributes (CPAs) and subsequent use of Design of experimentation (DOE).
• Establish the stability data for development batches in collaboration with the analytical team.
• Master document preparation like MFC, Scale up batch study protocol/ report, sampling plan, stability guidance documents, In-use stability study protocol/ report.
• Co-ordination with various CFT’S like sourcing, Project Management, analytical, Regulatory, Packing, Production, MSAT, DQA and clinical for smooth development of product.
• Compilation and preparation of pharmaceutical development report with respect to current QbD format.
• Responsible for preparation of Product Developmental Report (PDR) for filling.
• Handling of deviations, change control and OOS related to Exhibit batches.
• Preparation, updation of SOPs.
• Maintaining of batch, calibration and other necessary records.
• Subjecting required batches to stability studies.
• Successful demonstration of proof of concept and ensure prospective documentation in line with QbD paradigm.
• Discuss and deliberate needful measures for timely execution of batches and ensure regulatory filing, approval and launch of generic drug products.

• Ph.D. in Pharmaceutical Sciences with 3 Yrs +/ M.Pharm in Pharmaceutical Sciences with 6 to 10 years from reputed universities
• Experience in working in a high performance teams in known generic space/ organisations with known generic footprint in regulated markets. Viz. US/EU/Canada.

Technical skills

• Formulation Development of Solid Oral Dosage forms, exposure from development and submision to regulatory agencies.
• SME within team and Provides solutions to moderate problems within team.
• Frequent use of scientific theories and principles.
• Good learning acumen
• Basic level understanding on recent ICH, regulatory guidelines, IP requirements; understanding of Bioequivalence, GMP, Quality and SOP compliance, GLP etc.

People Skills

• Must be Confident, able to work in the team and a good team player
• Stable and calm, Supports functional colleagues
• Shows respect, listens effectively, show caring
• Strong technical communication skills, has the ability to take comprehend facts and data to help the decision making.
• Shows respect, listens effectively, show caring & be compliant with the core values of TEVA
• Demonstrates timeliness

Inter personal Skills

• Collaborates with team within functionional area and cross functional teams.
• Strong technical communication applied applied locally and contributor to local and/or global project teams.
• Delivers technical presentations & Recommends project strategy
• Ability to work with very little supervision, Train and supervise junior staff
• Ability to work independtly on individual products.
• Mentors functional colleagues.
• Manages internal and external partners.

• To analyze samples received from Formulation department (samples include in-process, finished product, pre-formulation study samples and stability samples etc.).
• To carry out analytical method development for API, in-process samples and finished products including the methods for cleaning studies. To carry out analytical method transfer activity.
• Calibration and maintenance of analytical instruments. Maintenance includes activities such as Qualification, keeping track of AMC, History, Spares, Usage records etc.
• To ensure that all activities undertaken are executed in the framework of good laboratory and documentation practices and the existing quality systems are adhered to.
• To ensure safety practices are followed during the execution of activities and strict adherence to the EHS systems of the site.
• Any other activity assigned but the line manager
• Trouble shooting of analytical instruments for difficulties faced during day-to-day operations

• PhD with 1 plus years of experience/ Masters degree in Pharmaceutical sciences/Msc
• 3 to 5 years relevant experience