32 Analytical Development Jobs - Page 2

Walk-In Interview Alert Metrochem Pharma API Pvt Ltd | Hyderabad Metrochem Pharma API Pvt Ltd is conducting a walk-in interview for various positions in the Production, Quality Control, IPQA, Synthesis R&D ,Analytical R&D,Warehouse,IT, EHS and Engineering departments for Hyderabad -Jeedimetla, Kazipally, Bonthapally Units. Date: Sunday, 01st June 2025 Time: 09:00 AM – 05:00 PM Venue: PNM High School, Metro Pillar No.: 823, Behind Ratnadeep Super Market, Kukatpally, Hyderabad, Telangana- 500072 Departments &Positions Available: Production – Chemist/Operator/Executive Engg&Utility – Technician/Executive/Sr.Associate Quality Control – Trainee Chemist/Chemist Quality Assurance – Trainee Chemist/Chemist Synthesis R&D – Trainee Chemist/Chemist/Research Associate Analytical R&D – Trainee Chemist/Chemist/Research Associate Warehouse – Officer/Executive EHS – Officer/Executive IT– Trainee Executive/Executive Eligibility Criteria: Qualifications: BSc Chemistry/MSc Chemistry/ITI / Diploma / D. Pharm / B. Sc / B. Pharm / M. Pharm / M. Sc / PG (role specific)/SSC to Master’s Degree. Experience: 0 to 10 Years Shift Operations: Willingness to work in shifts is mandatory Documents to Carry: Updated Resume Latest increment letter and last 3 months’ payslips Relieving & service certificates from previous organizations All educational documents Aadhar & PAN Role & responsibilities Preferred candidate profile

About The Role What you will do Let’s do this. Let’s change the world. Amgen is searching for a Manager for the Submission Process, Planning, and Management (SPPM) team within Global CMC & Device Regulatory Affairs in Amgen India (AIN). The mission of SPPM is to support productivity across the organization and stakeholders by: Driving continuous improvement of processes and tools Ensuring awareness of processes across the organization; and Shaping the training strategy across the organization The Manager in SPPM will be responsible for developing, maintaining, improving, and driving consistency across the practices and procedures related to CMC processes. Job responsibilities of the SPPM Manager include: Support the new hire onboarding program Facilitate communication across Global CMC & Device Regulatory Affairs to ensure process robustness and awareness Drive consistency across Global CMC & Device Regulatory Affairs Develop and maintain training materials Global CMC & Device Regulatory Affairs Train staff on select departmental processes and procedures Ensure consistent use of processes and tools across department Continuous improvement of templates for presentations, timelines, trackers, and other tools Liaise with functions in GRAAS and Operations to ensure alignment Participate in cross-functional special project teams Potential to oversee or manage staff What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 7 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Master’s/ Doctorate's degree and 8 to 12 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 10 to 13 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Technical & Functional Expertise: Bachelor’s degree or higher in Life Sciences, Engineering, or a related field Experience in Regulatory Affairs, CMC, Manufacturing, Quality Assurance/Control, Process Development, or Analytical Development in the pharmaceutical or biotechnology industry Working knowledge of Regulatory CMC processes and global submission requirements Experience developing or managing standard operating procedures (SOPs), process documentation, or training programs Familiarity with regulatory systems or tools (e.g., Veeva Vault RIM, electronic document management or submission platforms) Certification or formal training in project management (e.g., PMP, CAPM) or process improvement methodologies (e.g., Lean, Six Sigma) is a plus Collaboration & Communication Skills: Strong project management and organizational skills with the ability to manage multiple priorities Excellent written and verbal communication skills, with experience presenting to diverse audiences Demonstrated ability to collaborate across global, cross-functional, or matrixed teams Experience supporting onboarding, training, or continuous improvement initiatives Comfortable working in a fast-paced, deadline-driven environment with a focus on quality and consistency What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Analytical method development of API and itermediate. Handling of HPLC, GC, Karlfisher, potentiometry titration. Preparation of specification and STP. Titration expertise. Daily work reporting, literature search and trouble shooting in QC Labs.

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Senior Research Scientist ADL Job Requisitions No : 12504 Job Description Purpose of Job Skill Required Roles and Responsibilites Qualification Required Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Research Scientist ADL Job Requisitions No : 12812 Job Description Purpose of Job Senior Scientist role in Analytical development laboratory with an experience of 8+ years in biologics or biopharma domain or PhD in any life sciences with 4+ years of biopharma industrial experience In this proposed job role the scientist is expected to carry out analytical characterization and development activities required for biologics product development Method validation and method transfer related documentation will be key responsibility The person will drive the project from analytical front and will be representing analytical team in CFT discussions and project meetings Data interpretation and rationale decision making for analytical data related decisions and prioritizing deliverables will be key KPI Data compilation and presentation of analytical findings to project team and senior management as an when required The person is expected to lead a group of 4-6 scientists and manage daily activities of group, Skill Required Expertise in LC techniques Expertise in HOS techniques Scientific report writing and documentation Data presentation and data analysis Roles and Responsibilites Responsible for analytical method development of LC and HOS techniques, Perform analytical method qualification and write method qualification reports, Perform method validation and method transfer to QC and identified sites for qualified methods, Manages project work and independently executes experiments as and when required Derives interpretation and conclusion of results Plans daily work, records and reviews results and documents to ensure correctness and to fulfil targets on time Coordinates with other team members as per requirement, Perform literature search and develop newer and improved high throughput characterization workflows, Manage team of 4-6 junior scientists and involved in work allotment and daily activity planning, Assessing team performance and assisting senior scientists and managers during review process, Provide timely feedback and training to junior scientists Meeting analytical deliverables timelines set and agreed upon in project meetings, Qualification Required Sc/M Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Expertise in LC techniques Expertise in HOS techniques Scientific report writing and documentation Data presentation and data analysis Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025

Role & responsibilities Handling of Analytical Instruments like HPLC, Gas Chromatography, Dissolution, UV, pH and conductivity meter, Analytical Balances, etc. along with software. Analytical method development by HPLC & GC (Liquid Oral Dosage forms) Knowledge about ICH guidelines for Analytical method development and Validation by HPLC& GC. Calibration of HPLC, GC, Dissolution test apparatus, pH meter, KF Potentiometry and Balances. Analysis of Regular and stability samples. Preparation and Review of STP, Protocols and Analytical Reports. Following inhouse systems and Procedure to ensure the cGMP practices and regulatory requirements (US market) Preferred candidate profile Analytical method development using HPLC and GC for Liquid Orals , Topicals, Semi solids (US market). Experience in Nasal sprays will be added advantage. Analytical method development, routine and stability analysis using HPLC/GC instruments. Interested candidates may send CV to karthik.bonam@zolon.com

HOW MIGHT YOU DEFY IMAGINATION? You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission - to serve patients - drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role. Regulatory Affairs Manager – Devices What you will do Let’s do this. Let’s change the world. In this vital role you will support development and execution of regulatory strategies and filings for new and existing drug delivery devices and combination products, establishing sustainable processes, assuring informed relationships, and delivering strategic outcomes. Responsibilities: Support the development, communication, implementation, and maintenance of JAPAC regulatory strategic plans Lead and/or support JAPAC health agency engagements Lead and/or support JAPAC filing activities and associated health agency inquiries Support device design controls activities and documentation reviews Assess device-related standards and guidance for regulatory applicability; assist in establishing Amgen regulatory positions in the JAPAC region Perform change control regulatory assessments as it relates to JAPAC Develop and support implementation and maintenance of internal regulatory processes Perform device determination decisions for regulated items to be developed and/or used in JAPAC region Support supplier engagement teams and due diligence activities in the JAPAC region Review regulatory sections in development, quality, and supply agreements that impacts JAPAC region Support regulatory compliance initiatives in the JAPAC region What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a leader with these qualifications. Basic Qualifications: Doctorate degree; or Master’s degree and 2 years of pharma/biotech and/or medical device regulatory affairs experience; or Bachelor’s degree and 4 years of pharma/biotech and/or medical device regulatory affairs experience Preferred Qualifications: Master’s degree in regulatory affairs, engineering, or life sciences 6 or more years of experience in medical device regulatory affairs Experience in design controls, manufacturing, process development, quality assurance, quality control, or analytical development Experience in drug delivery device or diagnostics device regulatory submission process Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms