Senior Data Scientist II

Medical Affairs Lead

Head of Commercial Operations

Staff Engineer – Devices

Info Connector Assembly Process Engineer

Staff New Product Development Engineer

Staff Manufacturing & Process Development Engineer – Stamping

Staff Manufacturing & Process Development Engineer – Molding

Hardware Engineer

Quality Control Supervisor

About the Role : <ul><li>As a data scientist on our team, you will work on new product development in a small team environment writing production code in both run-time and build-time environments.&nbsp;</li><li>You will help propose and build data-driven solutions for high-value customer problems by discovering, extracting, and modeling knowledge from large-scale natural language datasets including matter and contract repository, invoice/legal spend data and work management.&nbsp;</li><li>You will prototype new ideas, collaborating with other data scientists as well as product designers, data engineers, front-end developers, and a team of expert legal data annotators.</li><li>You will get the experience of working in a start-up culture with the large datasets and many other resources of an established company.</li><li>We are committed to advancing gender diversity within the technology sector and supporting greater representation of women in tech. To further this commitment,</li></ul> Responsibilities: <ul><li>Develop and implement LLM-based applications tailored for legal use-cases&nbsp;</li><li>Evaluate and help maintain our data assets and training/evaluation data sets&nbsp;</li><li>Design and build pipelines for preprocessing, annotating, and managing legal document datasets&nbsp;</li><li>Collaborate with legal experts to understand requirements and ensure ML-applications meet domain-specific needs&nbsp;</li><li>Conduct experiments and evaluate model performance to drive continuous improvements&nbsp;</li><li>Fine-tune and deploy large language models to enhance their performance on legal text processing tasks&nbsp;</li><li>Interface with other technical personnel or team members to finalize requirements.&nbsp;</li><li>Work closely with other development team members to understand complex product requirements and translate them into software designs.&nbsp;</li><li>Successfully implement development processes, coding best practices, and code reviews for production environments.</li></ul> Requirements:&nbsp; <ul><li>Able to work in person 2 days per week&nbsp;</li><li>Bilingual English and Spanish&nbsp;</li><li>Practical experience with large language models, prompt engineering, fine-tuning RAG-based applications and benchmarking, using frameworks such as LangChain&nbsp;</li><li>MS in Data Science, Computer Science, Statistics, Machine Learning, or relevant work experience&nbsp;</li><li>Practical experience in Natural Language Processing methods and libraries such as spaCy, word2vec, Flair, BERT (ways to vectorize text data)&nbsp;</li><li>Formal training in machine learning: dimensionality reduction, clustering, embeddings, and sequence classification algorithms&nbsp;</li><li>Strong Python background&nbsp;</li><li>Knowledge of AWS, GCP, Azure, or other cloud platform&nbsp;</li><li>Understanding of data modeling principles and complex data models.&nbsp;</li><li>Proficiency with relational and NoSQL databases as well as vector stores (e.g., MySQL, Postgres, Solr, Elasticsearch/OpenSearch)</li><li>Knowledge of Spark-Scala, Ray or other distributed computing systems highly preferred&nbsp;</li><li>Knowledge of API development, containerization, and machine learning deployment highly preferred&nbsp;</li><li>Experience with ML Ops/AI Ops including experiment tracking tools like LangFuse and DVC&nbsp;</li><li>Experience with deep learning frameworks such as PyTorch, Tensorflow and Hugging Face Transformers Work in a way that works for you We promote a healthy work/life balance across the organization. </li><li>We offer an appealing working prospect for our people.&nbsp;</li><li>With numerous wellbeing initiatives, shared parental leave, study assistance and sabbaticals, we will help you meet your immediate. </li><li>Working flexible hours - flexing the times when you work in the day to help you fit everything in and work when you are the most productive.</li></ul>

Responsibilities: <ul><li>To effectively lead the Medical Affairs activities for segment across therapy areas, providing effective business enablement and high edge scientific activities towards achieving disease and therapy area leadership and enhancing access of products in disease and therapy areas of interest.</li><li>Help in evaluation of New Products for therapy prominence working portfolio and strategy team and marketing team.</li><li>Build connect with KOLs (Key Opinion Leaders) in shaping Therapy understanding and molecule understanding. CME/Ad board conduct ((Continuing Medical Education (CME)/(Medical) Advisory Board)), support guidelines , consensus etc.</li><li>To have scientific activities those are considered differentiated and purposeful for targeted audience.</li><li>Identifying need and planning evidence generation and post marketing studies.</li><li>Guide marketing teams in ensuring proper medical inputs and activities are delivered as per compliance.</li><li>Medico-marketing Support</li><li>Compliance in medico marketing activity</li><li>Evidence generation activities</li><li>Evaluation of New Products</li><li>Training and Development</li><li>Scientific Updates</li><li>Activities for Digital Platforms &amp; Other activities</li><li>Support Medical writing , Publication and communication</li></ul> Requirements: <ul><li>MD (Pharmacology/Medicine) / MBBS</li></ul> Experience: <ul><li>5-8 year in Medical Affairs -</li><li>Freshers with exceptional academic qualifications will be considered</li></ul> Skills: <ul><li>MS Office</li><li>Excellent written &amp; oral communication skills</li><li>Disease/Therapy Knowledge</li><li>Business Acumen</li><li>Excellent Relationship Building Skills</li><li>Broad Understanding of Medical Affairs&nbsp;</li><li>Confidence to interact with Internal &amp; External Stakeholders</li></ul>

Reponsibilities: Product Level Strategy <ul><li>Market data and internal financials</li><li>Strategy (gain share, hold share, rationalize volume, improve price, etc.)</li><li>Target share</li><li>Inventory targets based on market dynamics, product strategy, etc.</li><li>Provides input for Product Champions</li><li>Decision-making for Day-to-day Commercial Operations</li><li>Incorporate Product Strategies while leading/making the following decisions:</li><li>Order processing</li><li>ROFR responses</li><li>New business bids</li></ul> Rolling 12-month forecasts <ul><li>New Product Intel and Near-term Launch Evaluation &amp; Tracking</li><li>Maintain master database of future product pipeline information at the customer level.</li><li>Share with Portfolio as needed.</li><li>Assess the right frequency of pricing &amp; volume intel requirements</li><li>Interpret the accuracy of intel based on existing data points and those gathered via subscriber information (IQVIA, export data, etc.)</li><li>Rolling 12-month New Product Launch Prioritization and Planning</li></ul> Tracking results vs. business case on new launches <ul><li>Provide leadership for Product Management, Pricing/Contracts, Customer Service, Forecasting and Marketing</li><li>Identify/execute process improvements, including IT solutions</li><li>Manage all aspects of OTB strategies &amp; tactics (price, vol, production)</li><li>Improve UPS execution and shipping costs while analyzing other 3PLs</li></ul> Requirements: Qualifications Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>Bachelor’s or master’s degree preferred</li><li>10 plus years related work experience in the pharmaceutical industry, preferably generics</li><li>Excellent computer skills, including data collection experience</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Industry/Customer recognition</li><li>Financial acumen</li></ul> Skills &amp; Abilities <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific (e.g. coaching, negotiation, calibration, technical writing etc.)</li><li>Interpersonal Skills - Focuses on solving conflict; Maintains confidentiality; works well in a collaborative environment</li><li>Adapts to changes; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent changes or unexpected events. Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyones efforts to succeed.</li><li>Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs workflows and procedures.</li><li>Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.</li><li>Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.</li><li>Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.</li></ul> Physical Requirements <ul><li>Physical &amp; mental requirements (e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.)</li><li>General Office environment</li><li>Occasional Travel</li></ul>

Responsibilities: Design &amp; Development: <ul><li>Lead the design and development of drug combination products by understanding design space and managing critical design parameters.</li><li>Utilize SolidWorks and apply design for manufacturing (DFM) principles along with geometric dimensioning and tolerancing (GD&amp;T) to create sound engineering drawings.</li><li>Identify the best tools and approaches to effectively solve engineering problems.</li><li>Develop, optimize, and analyze designs using a combination of engineering principles, analytical methods, and experimental techniques.</li></ul> Technical Support &amp; Compliance: <ul><li>Support the evaluation and assessment of new technologies, intellectual property, products, and processes.</li><li>Provide support for existing products in terms of quality, manufacturing, and cost improvement.</li><li>Execute technical and cross-functional project work to ensure successful product development.</li><li>Develop and implement detailed test methods and write comprehensive technical reports based on design verification testing for design changes and product design activities.</li><li>Collaborate effectively with laboratory technicians and support staff.</li><li>Ensure compliance with quality policies, standard operating procedures, and regulatory requirements.</li></ul> Requirements: Regulatory &amp; Validation Expertise: <ul><li>Knowledge of Factory Acceptance Testing (FAT), Process Validation, and Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ).</li><li>Understanding of U.S. regulatory and quality requirements, including 21 CFR 820.3</li></ul> Experience: <ul><li>Minimum 8 years of engineering experience, with a preference for at least 5 years in product development.</li><li>Strong understanding of disciplined product development processes and quality requirements.</li><li>Experience in statistical tools, computer analysis, and engineering fundamentals for problem-solving.</li><li>Proficiency in SolidWorks is required.</li></ul> Skills &amp; Competencies: <ul><li>Strong interpersonal skills with the ability to collaborate effectively.</li><li>Excellent technical judgment and problem-solving abilities.</li><li>Demonstrated accountability for the successful completion of assigned tasks.</li></ul>

Responsibilities: <ul><li>Work with manufacturing team to develop new manufacturing process for NPI project.</li><li>Main focus on new project process, fixture design and documentation initiate.</li><li>Evaluation and approve manufacturing process (process flow, fixture, equipment etc. before mass production started).</li><li>Monitor product line and identify opportunity for improvement.</li><li>Review the process change request from manufacturing.</li><li>Review product design and provide DFM inputs.</li><li>Follow new project schedule to ensure the manufacturing process readiness.</li></ul> Requirements: <ul><li>6+ years experiences in manufacturing industry, or relevant.</li><li>Hands-on knowledge and skills on process development including fixture design, PFMEA draft , automotive equipment design.</li><li>Prefer the candidate from auto industry.</li><li>Familiar with connector process and mechanical assembly for small unit.</li><li>Lean manufacturing expert is desirable.</li><li>Familiar with Infotainment connector manufacturing and application, relevant experience is preferred.</li><li>Be familiar with Design for Manufacture (DFM) principles, workflow, PFMEA and methodology.</li><li>Good leadership and reporting skills; ability to communicate well at all levels internally and externally.</li><li>Knowledge of production processes such as cutting, bending, stamping, plating, assembly.</li></ul>

Role Objective: <ul><li>Responsible for Power Solution product development, which is majorly used for data communication or Hyperscale computers.&nbsp;</li><li>Provide customer innovation solutions as well as manage the engineer documents following our clients system procedure.</li></ul> Responsibilities: <ul><li>Collaborate with cross-functional teams to design, develop, and launch new power connector and cable assembly solution products for data center applications.</li><li>Provide leadership and manage the complete product development life cycle (starting from the voice of the customer, ideation, Design Conceptualization, Creation of product specifications, 3D design, Prototyping, Product testing, Product qualification, Project Execution &amp; Sustenance till product end of life)</li><li>Work closely with customer/sales/PM in getting the right and clear VOC (voice of customer), and make engineering evaluation/proposal to the customer.</li><li>Follow LEANPD Project Process to support the project team from the PDE perspective to complete the Project (NPI or Sustaining) on time, with quality, and within budget. Drive the development and release of products, scale-up through stage-gate reviews, ensuring milestone commitments are maintained.</li><li>Develop and manage product documentation, including product requirements, design documents, and test plans/reports.</li><li>Work with global manufacturing resources, procurement, and outside suppliers to meet all technical, quality, and cost objectives.</li><li>Work closely with suppliers to identify and qualify new components and technologies.</li><li>Conduct thorough design verification and validation testing to ensure the product meets the required specifications.</li><li>Collaborate with manufacturing teams to ensure a smooth transition to production.</li><li>Mentor and guide junior engineers and technicians to develop their skills and knowledge.</li><li>Conduct competitive analysis and market research to identify opportunities for innovation and differentiation.</li><li>Build a deep understanding of market and customer needs by fostering a connection between the business engineering teams and the customer engineering teams.</li><li>Maintain a System level understanding of customer application and the product design/concept necessary for providing a solution to the customers’ expectations.&nbsp;</li><li>Technical support to customer, sales, PM, and plant team. Conduct necessary tests, engineering analysis, troubleshooting, and verification.&nbsp;</li><li>Introduce breakthrough technologies by partnering technically with our customers worldwide and with our Global competency centers to enhance business revenue &amp; growth.&nbsp;</li><li>Apply engineering best practices to reduce cost and sustain existing products to meet customer’s cost targets.</li></ul> Requirements: Education/Knowledge: <ul><li>Bachelors or Masters degree in Mechanical or Electrical Engineering.</li><li>Strong understanding of mechanical and electrical engineering principles.</li><li>Experience with product development processes, including design, prototyping, and testing.</li><li>Strong problem-solving skills and ability to work independently or as part of a team.</li><li>Excellent written and verbal communication skills.</li><li>Experience with data center technology and connectors/cable assembly is a plus.</li><li>Project management skills and ability to manage multiple projects simultaneously.</li><li>Knowledge about various phases of product realization and product development</li><li>Knowledge of state-of-the-art design tools such as 3D Computer Aided Design (CAD), modeling, Geometric Dimension &amp; Tolerancing (GD&amp;T), electrical &amp; electronic design, and Simulation</li><li>Knowledge of manufacturing process (machining, molding, stamping, plating, etc.)</li><li>Knowledge of material (metal/plastic) properties will be a plus.</li><li>Familiarity with quality tools (FMEA, 6sigma, DOE, 8D…) will be a plus.</li></ul> Critical Experience: <ul><li>Minimum of 10 years of experience in product development, preferably in the technology industry with a minimum of 5 years in the Cable Assembly or connector related.</li><li>This highly technical position requires an individual who can work independently.</li><li>Experience in product compliance certification ( Product, Safety, Environmental substance control)</li><li>Experience in design for manufacturing and assembly (DFMA), design for cost (DFC), design for manufacturing (DFM).</li><li>Capability and experience in presentation on products, solutions, and technologies.</li><li>Previous experience in working in high-performing multi-disciplinary global engineering teams.</li></ul> Competencies: <ul><li>Technical capabilities: Expert functional/domain knowledge</li><li>Application Engineering: Ability to understand customer requirements &amp; offer engineering solutions</li><li>Engineering management across cross-functional teams: Developing technical roadmaps to align with market direction &amp; communicating it across business units, management &amp; customers to share applicable technology</li><li>Working together with the global team.</li><li>Optimizing engineering &amp; innovation: Defining &amp; managing IP strategy &amp; constantly improving products through R&amp;D</li><li>Building people capability: Training and mentoring engineers with the necessary skill set, assuring succession &amp; workforce planning &amp; organizational capability</li><li>Quality controller: Ability to assure quality for services, labels &amp; labs</li></ul> Motivational/Cultural Fit: <ul><li>Passion for technology</li><li>Talent development</li><li>Good communication skills and proactively communicate with team members and Customers</li><li>Effective planning &amp; Prioritization</li><li>Problem solving and Results driven</li></ul>

Responsibilities: <ul><li>Has strong impact in Advanced Manufacturing Technology Roadmap driven development projects.</li><li>Drives for excellence in existing Stamping technologies and methods.</li><li>Strives to implement optimized or new manufacturing technologies to provide improved processes and tolerance control.</li><li>Act as a liaison between the Advance Manufacturing Process team and the manufacturing sites teams to collaborate with Product Development in the optimization of part and product</li><li>Designs for manufacturability, providing stamping process expert knowledge and general knowledge of stamping processes to realize product samples and prototypes.</li><li>Provides stamping process expert knowledge and general knowledge and project management to liaise the Advance Manufacturing Process team and the manufacturing sites teams,</li><li>deploying optimized or new stamping processes to realize advanced manufacturing technology development projects.</li><li>Acts as the binding element between product development and advanced manufacturing &amp; process engineering, ensuring the effectiveness and efficiency of this critical interface.</li><li>Designs, develops, and qualifies stamping processes in compliance with company EH&amp;S, quality and production standards, as well as recognized best in class and industry standards.</li><li>Documents all related processes in applicable company systems.</li><li>Supports supply chain to verify related suppliers’ compliance and capability.</li><li>Initiates and implements stamping related programs to continuously improve quality, cost and cycle time.</li><li>Maintains and adheres to all appropriate specifications, regulatory and customer requirements.</li><li>Applies stamping process expertise to resolve significant / unique / complex issues, where analysis of situations or data requires an in-depth evaluation of variable factors.</li><li>Exercises considerable latitude in determining objectives and approaches to assignment, performing work without appreciable direction.</li><li>Drives results primarily through collaboration and influence, not through direct reporting relationships.</li><li>Provides training and mentorship to other professional employees.</li><li>Provides measurable input to the objectives and goals of the department in support of the function and business unit strategies.</li></ul> Requirements: <ul><li>Minimum 8 years of related experience.</li><li>Bachelor’s Degree (Mechanical Engineering or related) required, Master’s preferred.</li><li>Demonstrates stamping process expertise (process optimization, capability, troubleshooting)</li><li>Tight tolerance electrical connector experience is a plus!</li><li>Working knowledge with quality tools (FMEA, Six Sigma, DOE, 8D/Continuous Improvement), is a plus!</li><li>Fluent in English (read, write, and speak).</li><li>Broad knowledge of stamping, plating, and assembly processes for connectors and sockets is desired.</li><li>Practical application of MS Office software (Word, Excel, PPT, Project, &amp; Outlook).&nbsp;</li><li>Broad project management skill and experience – Ability to work on several projects at once.</li><li>Based in China-Qingdao or the Philippines-Batangas mfg. sites and willingness to travel up to 25% average.</li></ul>

Responsibilities:•	Has strong impact in Advanced Manufacturing Technology Roadmap driven development projects.•	Drives for excellence in existing Stamping technologies and methods.•	Strives to implement optimized or new manufacturing technologies to provide improved processes and tolerance control.•	Act as a liaison between the Advance Manufacturing Process team and the manufacturing sites teams to collaborate with Product Development in the optimization of part and product designs for manufacturability, providing stamping process expert knowledge and general knowledge of stamping processes to realize product samples and prototypes.•	Provides stamping process expert knowledge and general knowledge and project management to liaise the Advance Manufacturing Process team and the manufacturing sites teams, deploying optimized or new stamping processes to realize advanced manufacturing technology development projects.•	Acts as the binding element between product development and advanced manufacturing &amp; process engineering, ensuring the effectiveness and efficiency of this critical interface.•	Designs, develops, and qualifies stamping processes in compliance with company EH&amp;S, quality and production standards, as well as recognized best in class and industry standards.•	Documents all related processes in applicable company systems.•	Supports supply chain to verify related suppliers’ compliance and capability.•	Initiates and implements stamping related programs to continuously improve quality, cost and cycle time.•	Maintains and adheres to all appropriate specifications, regulatory and customer requirements.•	Applies stamping process expertise to resolve significant / unique / complex issues, where analysis of situations or data requires an in-depth evaluation of variable factors.•	Exercises considerable latitude in determining objectives and approaches to assignment, performing work without appreciable direction.•	Drives results primarily through collaboration and influence, not through direct reporting relationships.•	Provides training and mentorship to other professional employees.•	Provides measurable input to the objectives and goals of the department in support of the function and business unit strategies. Requirements:•	Minimum 8 years of related experience.•	Bachelor’s Degree (Mechanical Engineering or related) required, Master’s preferred.•	Demonstrates stamping process expertise (process optimization, capability, troubleshooting)•	Tight tolerance electrical connector experience is a plus!•	Working knowledge with quality tools (FMEA, Six Sigma, DOE, 8D/Continuous Improvement), is a plus!•	Fluent in English (read, write, and speak).•	Broad knowledge of stamping, plating, and assembly processes for connectors and sockets is desired.•	Practical application of MS Office software (Word, Excel, PPT, Project, &amp; Outlook).&nbsp;•	Broad project management skill and experience – Ability to work on several projects at once.•	Based in China-Qingdao or the Philippines-Batangas mfg. sites and willingness to travel up to 25% average.

Responsibilities: <ul><li>As a Hardware Engineer , you will focus on the electrical design, simulation, and verification-validation testing of high-speed products in cable assemblies targeting high-speed communications and connectivity within data centers and wireless infrastructure.</li><li>You will be expected to independently work on projects in hardware design and validation for product, and system design including modeling, simulation, testing, and circuit board layout.</li><li>You will work collaboratively within a broader cross-functional team of mechanical, manufacturing, &amp; operations to execute leading-edge product designs.</li><li>You will be the subject matter expert for the electrical performance of a product/platform beginning with the initial analysis through prototype fabrication &amp; evaluation, and production verification testing.</li><li>You will tackle challenging design problems and utilize simulation tools to guide complex designs toward success.</li></ul> Short Description <ul><li>Subject matter expert in high-speed data, electronics design, simulation, and validation activities through product development cycles.</li><li>Establishing electrical design performance/functional requirements for new products.</li><li>Product development of high-speed cable assemblies from conception to manufacturing.</li><li>Component selection, schematic design, PCB Layout, and product validation testing.</li><li>Creating actionable recommendations based on design reviews and simulation results.</li><li>Making data-driven decisions about the product functionality and areas for improvement.</li></ul> Requirements: What your background should look like: <ul><li>Bachelor’s degree in Electrical Engineering, Master’s degree preferred.</li><li>Minimum of 10 years of work experience in a high-speed hardware engineering role.</li><li>Electronic design and analysis tools (Altium PCB, ADS, Ansys Designer, Ansys HFSS).</li><li>Experience with cable/cable assembly designs (high-speed twin-ax cables, direct attach copper (DAC) cables, active copper cables).</li><li>Experience with high-speed test equipment (Digital Sampling Oscilloscope, Vector Network Analyzer, Bit Error Rate Tester, TDR, Pattern Generators, Power Supplies, etc.)</li><li>Experience with signal conditioning techniques (equalization, amplification, FIRs, CTLEs).</li><li>Experience with component selection, schematic capture, printed circuit board design, fabrication, and assembly.&nbsp;</li><li>A solid understanding of electromagnetic theory and electrical circuit behavior.</li><li>Strong analytical capabilities to interpret simulation and lab data to identify issues and provide solutions to fix identified problems.&nbsp;</li><li>Experience in project leadership, especially as it applies to design, development &amp; manufacturing teams.</li><li>Excellent verbal and written communication skills.</li><li>Ability to work in a global environment – able to accommodate varying time zones, fluent in English (verbal/written), able to collaborate with individuals across geographies.</li><li>The individual must be highly motivated, a quick learner, and able to work independently.</li></ul>

Role Description: <ul><li>A concise overview of the job The Supervisor, Quality Control is responsible for overseeing the day-to-day operations of the QC raw material testing group.</li><li>Supervision and enforcing cGMP’s, GLP’s, conducting investigations, method transfers, verifications of compendia methods and training of new employees.</li><li>All incumbents are responsible for following applicable Division &amp; Company policies and procedures.</li><li>Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&amp;L responsibility, etc.</li><li>Supervisory responsibilities within a single site.</li></ul> Responsibilities: <ul><li>QC Lab Management- Supervise day-to-day operations of QC Laboratory to ensure that cGMP’s, GLP’s and all other applicable compendial requirements are met.</li><li>Ensure that the testing is done as per the approved monograph procedures, investigate and take corrective actions, document investigation findings and coordinate the approval process of investigations.</li><li>Interact with Planning, Purchasing, Supply Chain, Production, QA for timely release of raw materials, excipient and packaging components.</li><li>Coordinate Analytical Methods Transfer projects. Identify and implement procedures to reduce cost of goods.</li><li>Develop systems and processes for proactive management of laboratory logistics and instrumentation.</li><li>Oversee ordering of lab supplies in observance of Departmental Budget constraints.</li><li>Workload Management- Coordinate workload sharing with other groups in QC and develop action plans to improve the working environment and for maximization of laboratory efficiency.</li><li>Prepare monthly report of the issues, work done, any employee related issues and conduct bi-weekly audits of the analyst’s notebooks.</li><li>SOPs - Review/update SOP’s, procedures and monographs for the QC Group as needed.</li><li>Review and comment on the articles affecting QC in the USP Supplements and Pharmacopeial Forums.</li><li>Conduct periodic audits of the analyst notebooks and instrument logbooks to ensure compliance of cGMP’s.</li><li>Staff Development-Evaluate potential candidates for QC; performance evaluation of direct reports.</li><li>Provide training in all procedures/instrumentation/techniques, including but not limited to HPLC, UV-Vis, IR, and Raw Material, Finished Product, Stability testing. 15% Total	100% Qualifications&nbsp;</li></ul> Requirements: Education &amp; Experience <ul><li>Minimal acceptable level of education, work experience and certifications required for the job</li><li>BS in chemistry or related discipline with 10+ years’ experience in pharmaceutical testing OR MS in Chemistry or related discipline with 7+ years’ experience in pharmaceutical testing.</li><li>3+ years’ QC lab supervisory experience in pharmaceutical industry.</li><li>Demonstrated management and leadership experience with strong interpersonal and influencing skills.</li></ul> Knowledge&nbsp; <ul><li>Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.</li><li>Expert knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or SDS.</li><li>Strong knowledge and proficiency required with laboratory techniques/instruments, such as HPLC, GC, analytical balance, pipette, burette, oven, UV-vis spectrophotometer, dissolution tester, pH meter, etc.</li><li>Strong knowledge and proficiency preferred with Empower, Track Wise and Labware LIMS.</li></ul> Skills &amp; Abilities	 <ul><li>Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.</li><li>Organizational Support- Follows policies and procedures; completes administrative tasks correctly and on time; supports organizations goals and values; benefits organization through outside activities; supports affirmative action and respects diversity.</li><li>Leadership - Exhibits confidence in self and others; inspires and motivates others to perform well; effectively influences actions and opinions of others; accepts feedback from others; gives appropriate recognition to others.</li><li>Supervising People- Includes staff in planning, decision-making, facilitating and process improvement; takes responsibility for subordinates activities; is available to staff; provides regular performance feedback; develops subordinates skills and encourages growth; solicits and applies customer feedback (internal and external); fosters quality focus in others; improves processes, products and services.; continually works to improve supervisory skills.</li><li>Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.</li><li>Demonstrated flexibility in carrying out varied assignments in a high-quality work environment.</li><li>Excellent written and oral communications skills with a strong emphasis on organizational capabilities.</li></ul> Physical Requirements	 <ul><li>Physical &amp; mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.</li><li>Employee is frequently required to use hands to handle or feel.</li><li>The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and color vision.</li><li>The noise level in the work environment is usually moderate.</li><li>The work environment is representative of a group laboratory environment.</li><li>QC Lab Management, Workload Management, SOPs, Staff Development</li></ul>

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33 economic evaluation Jobs found

Senior Data Scientist II

Medical Affairs Lead

Head of Commercial Operations

Staff Engineer – Devices

Info Connector Assembly Process Engineer

Staff New Product Development Engineer

Staff Manufacturing & Process Development Engineer – Stamping

Staff Manufacturing & Process Development Engineer – Molding

Hardware Engineer

Quality Control Supervisor

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Skills

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33 economic evaluation Jobs found

Senior Data Scientist II

Medical Affairs Lead

Head of Commercial Operations

Staff Engineer – Devices

Info Connector Assembly Process Engineer

Staff New Product Development Engineer

Staff Manufacturing & Process Development Engineer – Stamping

Staff Manufacturing & Process Development Engineer – Molding

Hardware Engineer

Quality Control Supervisor

WhiteCrow WhiteCrow is on a mission to connect companies with the best talent across the globe.

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TALENT

COMPANY

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WhiteCrow
WhiteCrow is on a mission to connect companies with the best talent across the globe.