דרושים Analytical Chemist Year Contract ב-Boston Scientific ב-מלזיה

remote working, preferably based in the area of Málaga.

About The Role

Field Clinical Specialist (FCS) provides field technical & educational support to assigned accounts at a Territory level. Work is driven by Customer demand and pre-planned support requirements. The primary focus is with case support but using clinical expertise to influence Customer usage of the full portfolio.

Your Responsibilities Will Include:

• Provides field clinical support in the areas of supporting case coverage, basic troubleshooting, programming, and patient follow-up for company products.
• Work is driven by Customer demand and pre-planned support requirements.
• Attend cases face to face with our customer and advise physicians on clinical attributes / techniques associated with our products.
• Ensure timely collection, reporting of all required medical documentation pertaining to our procedural device operation.
• Supports team to achieve projected sales goals and increase sales revenues.
• Develops deep understanding on the workflows and specificities of each hospital & business relationships with hospital personnel (e.g., through informal conversation, meetings, participation in conferences) to make new contacts in other departments within hospital and to identify key decision makers in order to facilitate future sales.
• Responds to complex customer needs and complaints regarding products and service by developing creative and feasible solutions or working with other related personnel (e.g., sales, clinical, research, marketing, technical support) to develop optimal solutions.
• Records customer information and activities in company’s CRM system: use the system as an alignment tool with other commercial roles.
• Provides education support on product usage and customer training.

What We Are Looking For In You:

• Degree in Biomedical Engineering (preferred) or Nursing, Pharmacy, Biotechnology or similar;
• Native or proficiency in Spanish and good English level;
• Any small experience (around 1 year) in a similar role or in the operating room, with preference in the Neuromodulation or Neurosurgery field, will be considered a plus;
• Based preferably in the area of Málaga.

What Can We Offer You

• Permanent contract
• Company car
• Healthy work-life balance with flexibility and respect for personal time.
• Working in an international environment with diverse, high-performing colleagues.
• Inspirational colleagues & culture that empower creativity, accountability, and excellence.
• Career Development opportunities through dedicated training programs and stretch assignments.

Purpose Statement:

Job Responsibilities:

• Primary Commitment to patient safety and product Quality.
• Understands and comply with all the regulations governing the quality systems.
• Delivery of key Quality and Performance Objectives. Maintenance of laboratory scorecards and trackers.
• Ensure compliance with mandatory training requirements and ensure that your training records are up to date and compliant to cGMP.
• Your responsibilities may include test method development and validation, raw material, in process, finished product and Stability testing.
• Complete documentation associated with testing/ method development & Validation/ equipment qualification in a timely manner.
• Ensure all analytical testing is carried out as defined in the Quality System.
• Perform equipment and qualification per USP <1058> Analytical Instrument Qualification and GAMP5: A Risk-based Approach to Compliant GxP Computerized Systems as required.
• Review of all laboratory Quality Systems to ensure compliance to cGMP.
• Participate in Regulatory, Internal (Auditor/Auditee) and Vendor audit programs as required.
• Provide training (induction/ on the job/ procedures and updates), technical guidance / trouble shooting to laboratory staff including review of associated training records.
• Review and approval of Laboratory results and documentation, as required the trending and charting of data.
• Perform and assist with additional duties as may be directed by the Lab Management.
• Provide analytical support to process validations.
• Proficient in the use of various software application utilized in the laboratory, i.e LIMS, Waters Empower. As required the development configuration and validation of software in accordance with Boston Scientific and Industry standards.
• Create, review and approve change requests as required.
• Creation of purchase requisitions for laboratory equipment and consumables.
• Management of laboratory inventory and supplies and ordering of same.
• Participate on LBP/VIP/Quality Catch/Preventive CAPA and Continuous project teams as required.
• Coordinate Preventive Maintenance and Calibration activities for equipment and ensure no event of Calibration/PM overdue.
• Participate in OOS investigations, utilizing technical knowledge to identify assignable cause and corrective actions.
• Manage/handle lifecycle management of an equipment, i.e., Procurement, Commissioning, Qualification Maintenance, Calibration, troubleshooting, availability of contingency equipment and Retirement of the equipment and software.
• Perform all in-house (Lab scope) Calibration, Preventive Maintenance, Temperature Mapping, Software Maintenance (scheduled data backup, disaster recovery exercise and data archival).
• Routinely inspect the Equipment for proper use and care by the analyst.
• Initiate and own NCEP/CAPA as per required.
• Review and approve laboratory data packs to confirm if they meet the quality requirements.

• Works as a member of the Penang Analytical Laboratory (PAL) Team to complete all required analysis in a timely manner.
• Capable of operating analytical instruments (HPLC, GCFID/MS, Karl Fischer, Dissolution Apparatus, UV-Vis and FTIR)
• Capable of preparing buffers, mobile phase, reagents and media needed for analysis
• Provide testing evaluation of raw materials, intermediates, and finished products samples based on specifications
• Perform investigations into suspected analytical lab testing results i.e. OOS, OOT, atypical data etc.
• Interprets and applies department policies and procedures and applicable laws, rules, and regulations
• Understand and precisely follows Standard Operating Procedures, global methods, local methods and published standard or compendia methods USP, AOCS, ASTM
• Render appropriate dispositions for all sample lots with test results outside specified limits
• Use analytical and problem solving skills to solve manufacturing issues/ problems related to Analytical Chemistry Science and contaminations.
• Maintain calibration of specific laboratory equipment as outlined in the calibration procedure
• Troubleshooting of Analytical equipment and associated Lab software
• Perform Analytical equipment qualifications, Analytical method validation/ verification activities
• Maintain standardization and replenishment of all laboratory volumetric solutions and reagents
• Ensure all samples no longer needed are boxed and properly identified for disposal

• BSc or higher in chemistry or relevant scientific discipline
• Basic computer skills such as Word, Excel
• Ability to follow all methods and procedures in strict compliance with FDA cGLP guidelines
• Must be comfortable working on individual projects leading/participating in a team across various functions to deliver results on tight timelines
• Expertise and practical laboratory experience
• At least 1-2 years of experience with HPLC/ GCFID/MS along with other analytical instrumentation
• Excellent written, oral, and visual communication skills to communicate effectively with all levels and teams of the organization

Job Summary

Key Responsibilities

Preparation, negotiation, analysis, escalation, and finalization of all site agreements and budgets

• Customizes Agreement and Budget Templates: Leverages historical site data to tailor the agreement and budget templates specifically for each site, ensuring relevance and accuracy.
• Coordinates with Site for Contract Execution: Engages with site representatives to align on expectations and timelines for contract execution, aiming to meet the targeted authorization date efficiently.
• Conducts Budget Analysis and Negotiation: Reviews and analyzes the proposed budget against Fair Market Value (FMV) parameters. Utilizes historical data to negotiate site requests, ensuring consistency and fairness across site and study budgets.

Accelerate negotiations by using budget parameters

• Negotiates Site Budgets: Utilizes the fair market value established at the study’s inception to negotiate budgets with sites, ensuring financial alignment and transparency.
• Reviews and Analyzes Costs: Examines requested costs to determine their applicability to the specific phase and indication of the trial, ensuring budgetary compliance and relevance.
• Escalates Unresolved Fees: Escalates any fees that sites refuse to decrease or waive, gathering all necessary cost justifications to present to the Fair Market Value team for further review.
• Engages in Site Discussions: Participates in calls with site representatives to gain a deeper understanding of their requests, fostering clear communication and effective negotiation.

Working with legal stakeholders to negotiate contracts

• Collaborates with BSC Legal Team: Works closely with the BSC legal department to negotiate and establish mutually agreeable terms between the institution and the sponsor, ensuring all parties’ interests are adequately represented.
• Drafts and Finalizes Amendments: Develops necessary amendments for ongoing trials, coordinating with the legal team to finalize these documents for site execution during the maintenance phase, ensuring compliance and smooth operation.
• Manages Contract Concerns: Addresses and resolves contract-related issues by liaising with various divisions, effectively navigating potential standoffs and facilitating successful contract negotiations.

Maintain regular communication and escalation to expedite the planning, execution, issue resolution, and management of Site/Investigator agreements.

• Communicates Site Concerns with Trial Managers: Engages in discussions with trial managers to address and resolve any concerns raised by sites, ensuring smooth and effective trial operations.
• Highlights Contract and Budget Issues: Proactively brings any contract and budget-related concerns to the attention of trial managers as they arise during the study, facilitating timely resolution and maintaining financial integrity.
• Monitors and Supports Site Performance: Identifies sites that are not meeting established timelines and coordinates calls with the trial team to set clear goals and strategies for getting the site back on track, ensuring adherence to project schedules.
• Understand Site Activation requirements versus contracting turnaround times to support study site authorization
• Coordinates with TCRAs for Contract Timelines: Works closely with TCRAs to establish a timeline for contract execution, facilitating the planning of site authorization and enabling timely patient enrollment in critical trials.
• Routinely Reassesses Timelines with Study Team: Regularly checks in with the study team throughout the study start-up phase to reassess contract and budget timelines, identifying and navigating potential barriers to ensure adherence to target dates.

Job Qualifications:

• Bachelor’s degree, or equivalent experience
• Minimum of 1 years Industry experience managing clinical site contracts & budgets
• Demonstrates effective time management skills, including the ability to prioritize multiple tasks independently
• Demonstrates the ability to work independently and take initiative to prevent and resolve issues
• Demonstrates the ability to have strong analytical and organizational skills
• Demonstrates the ability to communicate effectively in English, both in writing and orally
• Demonstrates interpersonal skills demonstrated by being proactive, customer-focused, and independent critical thinker

Responsibilities

• Manage the execution country expansion strategies to achieve short- and long-term business objectives.
• Identify, evaluate and manage business opportunities/leads in securing sales pipeline in line with short- and long-term financial goals.
• Manage the negotiation process. Prepare contracts, providing inputs on proper pricing and contract terms. Identify upselling opportunities and manage contract renegotiations with existing clients.
• Manage the improvement of current Business Development processes and cross-functional collaboration to drive effectiveness and minimize redundancy.
• Drive and coordinate activities related to Business Development workforce capability and client/customer data management.
• Collaborate with internal stakeholders in identifying upselling opportunities, deal negotiations and finalization of contracts.
• Establish long-term relationships with potential clients/customers with the view to enhance business opportunities.
• Maintains awareness of industry, competition, health care and economic trends and their impact on franchise short-term and long-term business plans adjusting plans as needed to reflect market conditions.
• Identifies new business opportunities and accounts by developing and leveraging relationships with academic and research institutions and Key Opinion Leaders; Develops and executes sales strategies and activities.
• Identifies new business opportunities and accounts by developing and leveraging relationships with academic and research institutions and Key Opinion Leaders.
• Ensures increasing numbers of patient treatment and clinical success through the education and training of physicians and hospital staff including patient identification and referral, implant, follow-up and on-going patient monitoring procedures.
• Works in close cooperation with the ASEAN regional team in developing and maintaining working relationships with the economic buyer in their region’s key accounts; Covering new contract designs and negotiations involving all products & solutions within the defined territory
• Educates local channel partners to take over projects in identified accounts after successful project implementation and focus on developing the next account.
• Acts as an interface with Customers and the Sales Organization with direct responsibility to facilitate, share documents and processes to identify, notify and ensure any complaints or problems are addressed, thereby demonstrating high commitment to Quality in all interactions and behaviors; Guides the local Leadership Team to maintain full compliance with the BSC Quality System (Corporate Quality Manual and Procedures) and the local quality requirements under the initiative of International Quality

Qualification

• Bachelor’s degree in Business, Life Sciences, Healthcare, or related field.
• Preferred: Advanced degree (MBA, Master’s in Healthcare Management) is a plus.
• Minimum 5 years of relevant experience in medical device sales, business development, or market development in the healthcare/medical device industry.
• Experience in direct sales or market development with a focus on engaging KOLs, hospitals and distributors.
• Proven track record of driving business growth in underdeveloped markets.
• Strong communication and negotiation skills.
• Self-starter with the ability to work independently with minimal supervision
• Experience in managing distributor markets is highly preferred, with a focus on emerging markets, particularly in the ASEAN region.
• Demonstrated expertise in sales and business development, especially in healthcare or medical devices.
• Excellent relationship-building and networking skills, particularly with KOLs, hospitals and medical societies.
• Proficient in negotiation and contract management, with the ability to plan and execute market development strategies.
• Skilled in delivering presentations and training for clinical education.
• Analytical thinker with strong problem-solving skills. Collaborative team player with experience in cross-functional coordination.

• Works as a member of the Penang Analytical Laboratory (PAL) Team to complete all required analysis in a timely manner.
• Capable of operating analytical instruments (HPLC, GCFID/MS, Karl Fischer, Dissolution Apparatus, UV-Vis and FTIR)
• Capable of preparing buffers, mobile phase, reagents and media needed for analysis
• Provide testing evaluation of raw materials, intermediates, and finished products samples based on specifications
• Assist Chemist with the investigations into suspected analytical lab testing results i.e. OOS, OOT, atypical data etc.
• Interprets and applies department policies and procedures and applicable laws, rules, and regulations
• Understand and precisely follows Standard Operating Procedures, global methods, local methods and published standard or compendia methods USP, AOCS, ASTM
• Escalate to Lab management for all sample lots with test results outside specified limits
• Maintain calibration of specific laboratory equipment as outlined in the calibration procedure
• Work with Chemist to support troubleshooting activities of Analytical equipment and associated Lab software
• Assist Chemist to perform Analytical equipment qualifications, Analytical method validation/ verification activities
• Maintain standardization and replenishment of all laboratory volumetric solutions and reagents
• Assist with Lab consumables inventory management and initiate procurement when safety stock reached
• Ensure all samples no longer needed are boxed and properly identified for disposal

• Diploma in Science or higher majoring in chemistry or any other relevant scientific discipline
• Basic computer skills such as Word, Excel
• Ability to follow all methods and procedures in strict compliance with FDA cGLP guidelines
• Must be comfortable working on individual projects leading/participating in a team across various functions to deliver results on tight timelines
• Expertise and practical laboratory experience
• Preferably 1-2 years of experience with HPLC/ GCFID/MS along with other analytical instrumentation
• Excellent written, oral, and visual communication skills to communicate effectively with all levels and teams of the organization

Purpose Statement:

The purpose of the Chemist role is to conduct analytical testing on commercial, stability and non-routine samples, in addition to participate in the test method development, validation and technical transfers as required. They are responsible for ensuring that all testing is carried out in accordance with cGMP.

Job Responsibilities:

• Primary Commitment to patient safety and product quality.
• Understands and comply with all the regulations governing the quality systems.
• Delivery of key Quality and Performance Objectives. Maintenance of laboratory scorecards and trackers.
• Ensure compliance with mandatory training requirements and ensure that your training records are up to date and compliant to cGMP.
• Your responsibilities may include analysis of raw material, in-process, finished product, Stability and process validation samples.
• Complete documentation associated with testing/ method development & Validation/ equipment qualification in a timely manner.
• Ensure all analytical testing is carried out as defined in the Quality System.
• Perform equipment qualification per USP <1058> Analytical Instrument Qualification and GAMP5: A Risk-based Approach to Compliant GxP Computerized Systems as required.
• Perform all in-house (Lab scope) Calibration, Preventive Maintenance, Temperature Mapping, Software Maintenance (scheduled data backup, disaster recovery exercise and data archival).
• Review of all laboratory Quality Systems to ensure compliance with cGMP.
• Participate in Regulatory, Internal (Auditor/Auditee) and Vendor audit programs as required.
• Perform and assist with additional duties as may be directed by the Lab Management.
• Proficient in the use of various software application utilized in the laboratory, i.e LIMS, Waters Empower. As required the development configuration and validation of software in accordance with Boston Scientific and Industry standards.
• Create, review and approve change requests as required.
• Creation of purchase requisitions for laboratory equipment and consumables.
• Management of laboratory inventory and supplies and ordering of same.
• Participate on LBP/VIP/Quality Catch/Preventive CAPA and Continuous project teams as required.
• Participate in OOS investigations, utilizing technical knowledge to identify assignable cause and corrective actions.
• Initiate and own NCEP/CAPA as per required.
• Conduct initial reviews of laboratory data packs to ensure accuracy and completeness.

Job Requirements:

• Candidate must possess at least a Bachelor's Degree in Chemistry, Analytical Chemistry, Applied Science or Life Science.
• At least 2-5 years of experience in Analytical Lab set-up, Analytical equipment qualification and Chemical Analysis.
• Required skill(s): FTIR, HPLC, GCMS, GCFID Analytical Analysis and equipment qualifications.
• Experience in LIMS set-up and empower software is preferable.
• Knowledge of GMP, GLP, ISO13485 will be added value.
• Required language(s): English